Background
Several non‐randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, ...but scientific evidence is lacking. The aim was to compare short‐term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy.
Methods
An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes.
Results
A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95–215) versus 123 (60–240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4–9·5) versus 8·7 (5–13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2–19) versus 6·6 (2–23) days; P = 0·194).
Conclusion
Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 (
http://www.clinicaltrials.gov).
Antecedentes
Varios estudios no aleatorizados y retrospectivos sugieren que la anastomosis intracorpórea (intracorporeal anastomosis, IA) tiene ventajas sobre la anastomosis extracorpórea (extracorporeal anastomosis, EA) en la colectomía laparoscópica derecha, pero no hay suficientes evidencias científicas. El objetivo del estudio fue comparar los resultados a corto plazo y definir los posibles beneficios de la anastomosis intracorpórea versus extracorpórea en la colectomía derecha laparoscópica electiva.
Métodos
Se realizó un ensayo clínico prospectivo y aleatorizado de mayo de 2015 a junio de 2018. El criterio de valoración principal fue la duración de la estancia hospitalaria. Los criterios de valoración secundarios fueron los eventos técnicos intraoperatorios y los resultados clínicos postoperatorios.
Resultados
Se aleatorizaron 140 pacientes. El tiempo quirúrgico fue más largo para la IA que para la EA (149,49 ± 27,24 versus 123,35 ± 36,56 min; P = 0,001). La longitud de la herida fue más corta en la IA (6,65 ± 1,21 versus 8,72 ± 1,44 cm; P < 0,001). La función digestiva se recuperó antes en la IA que en la EA (2,3 versus 3,3 días, P = 0,003) y la incidencia de íleo paralítico fue menor (13% versus 30%, P = 0,022). Los requisitos de analgesia postoperatoria fueron menores con la IA (39 ± 24,3 versus 53 ± 26; P < 0,001) y la puntuación de dolor (EVA) también fue menor (P < 0,035). El descenso de la hemoglobina en el postoperatorio y la hemorragia gastrointestinal baja fueron menores en la IA que en la EA (‐8,83 ± 1,7 versus ‐17,07 ± 1,7 mg/dl; P = 0,001) y (2,8% versus 14%; P = 0,031), respectivamente. La clasificación de Clavien‐Dindo mostró que la IA se asoció con resultados significativamente mejores que la EA: grado I (10% versus 27% P = 0,016); grado II (18% versus 35%, P = 0,0369). La puntuación del índice de complicación integral (comprehensive complication index, CCI) fue menor en el grupo IA (5,33 ± 9,2 versus 11,15 ± 14,34; P = 0,006). La estancia hospitalaria fue más corta en el grupo de IA pero sin diferencia significativa (5,65 ± 3,75 versus 6,58 ± 4,63 días; P = 0,194).
Conclusión
La IA presenta ventajas clínicas sobre la EA en la colectomía derecha laparoscópica.
The objective of this RCT was to compare short‐term outcomes and to define the possible benefits of intracorporeal compared with extracorporeal anastomosis in elective laparoscopic right colectomy. An intracorporeal anastomosis was shown to have clinical advantages over an extracorporeal anastomosis for laparoscopic right colectomy.
Better inside
The standard treatment of T2-T3ab,N0,M0 rectal cancers is total mesorectal excision (TME) due to the high recurrence rates recorded with local excision. Initial reports of the combination of ...pre-operative chemoradiotherapy (CRT) and transanal endoscopic microsurgery (TEM) have shown reductions in local recurrence. The TAU-TEM study aims to demonstrate the non-inferiority of local recurrence and the improvement in morbidity achieved with CRT-TEM compared with TME. Here we describe morbidity rates and pathological outcomes.
This was a prospective, multicentre, randomised controlled non-inferiority trial including patients with rectal adenocarcinoma staged as T2-T3ab,N0,M0. Patients were randomised to the CRT-TEM or the TME group. Patients included, tolerance of CRT and its adverse effects, surgical complications (Clavien–Dindo and Comprehensive Complication Index classifications) and pathological results (complete response in the CRT-TEM group) were recorded in both groups. Patients attended follow-up controls for local and systemic relapse. Trial registration: NCT01308190.
From July 2010 to October 2021, 173 patients from 17 Spanish hospitals were included (CRT-TEM: 86, TME: 87). Eleven were excluded after randomisation (CRT-TEM: 5, TME: 6). Modified intention-to-treat analysis thus included 81 patients in each group. There was no mortality after CRT. In the CRT-TEM group, one patient abandoned CRT, 1/81 (1.2%). The CRT-related morbidity rate was 29.6% (24/81). Post-operative morbidity was 17/82 (20.7%) in the CRT-TEM group and 41/81 (50.6%) in the TME group (P < 0.001, 95% confidence interval 42.9% to 16.7%). One patient died in each group (1.2%). Of the 81 patients in the CRT-TEM group who received the allocated treatment, 67 (82.7%) underwent organ preservation. Pathological complete response in the CRT-TEM group was 44.3% (35/79). In the TME group, pN1 were found in 17/81 (21%).
CRT-TEM treatment obtains high pathological complete response rates (44.3%) and a high CRT compliance rate (98.8%). Post-operative complications and hospitalisation rates were significantly lower than those in the TME group. We await the results of the follow-up regarding cancer outcomes and quality of life.
•CRT-TEM treatment achieves high rates of pathological complete response (44.3%).•CRT-TEM treatment achieves a high CRT compliance rate (98.8%).•Post-operative complications and hospitalisation rates were significantly lower than those in the TME group.•The accuracy of the endorectal ultrasound, rectal magnetic resonance imaging in the CRT-TEM group was not as high as expected.
Background
Although laparoscopic splenectomy (LS) has become the standard approach for most splenectomy cases, some areas still remain controversial. To date, the indications that preclude ...laparoscopic splenectomy are not clearly defined. In view of this, the European Association for Endoscopic Surgery (EAES) has developed clinical practice guidelines for LS.
Methods
An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. A consensus development conference using a nominal group process convened in May 2007. Its recommendations were presented at the annual EAES congress in Athens, Greece, on 5 July 2007 for discussion and further input. After a further Delphi process between the experts, the final recommendations were agreed upon.
Results
Laparoscopic splenectomy is indicated for most benign and malignant hematologic diseases independently of the patient’s age and body weight. Preoperative investigation is recommended for obtaining information on spleen size and volume as well as the presence of accessory splenic tissue. Preoperative vaccination against meningococcal, pneumococcal, and
Haemophilus influenzae
type
B
infections is recommended in elective cases. Perioperative anticoagulant prophylaxis with subcutaneous heparin should be administered to all patients and prolonged anticoagulant prophylaxis to high-risk patients. The choice of approach (supine anterior, semilateral or lateral) is left to the surgeon’s preference and concomitant conditions. In cases of massive splenomegaly, the hand-assisted technique should be considered to avoid conversion to open surgery and to reduce complication rates. The expert panel still considered portal hypertension and major medical comorbidities as contraindications to LS.
Conclusion
Despite a lack of level 1 evidence, LS is a safe and advantageous procedure in experienced hands that has displaced open surgery for almost all indications. To support the clinical evidence, further randomized controlled trials on different issues are mandatory.
Background
The incidence of perineal hernia after abdominoperineal excision and extralevator abdominoperineal excision ranges from 1 to 26%. In this systematic review, we compared surgical options ...and postoperative outcomes of perineal hernia repair in this setting from 2012 to 2016 with findings in a review of publications 1944–2011.
Methods
We searched the PubMed database using the keywords “hernia” AND “perineum” identified 392 papers published from 1946 to 2016. Two hundred and ninety-six papers published before 2012 were excluded and 96 were found to be potentially relevant.
Results
Twenty-one studies with a total of 108 patients were included in the final analysis. Perineal hernia repair was performed using the perineal approach in 75 patients (69.44%), the laparoscopic approach in 25 patients (23.14%), the open abdominal approach in three patients (2.77%) and the laparoscopic perineal approach in three patients (2.77%) and the open abdominoperineal approach in two patients (1.8%). Non-absorbable mesh was used in 41 (37.96%) of cases, composite mesh in 20 (18.51%) and biological mesh in 19 (17.59%). Flap reconstruction was used in 25 patients (23.14%). First and second recurrences were observed in 26 (24.07%) and 7 (26.92%) cases, respectively.
Conclusions
Comparison of perineal hernia repair from 1944 to 2011 and from 2012 to 2016 showed that perineal and laparoscopic approaches are currently the most commonly used techniques. Primary defect closure was abandoned in favor of synthetic or composite mesh placement. Use of flap reconstruction spread rapidly and the recurrence rate was low. Randomized control trials and a larger sample size are needed to confirm these data and to develop a gold standard treatment for secondary hernia repair after abdominoperineal excision or extralevator abdominoperineal excision.
Aim
The oncological risk/benefit trade‐off for laparoscopy in rectal cancer is controversial. Our aim was to compare laparoscopic vs open surgery for resection of rectal cancer, using unselected data ...from the public healthcare system of Catalonia (Spain).
Methods
This was a multicentre retrospective cohort study of all patients who had surgery with curative intent for primary rectal cancer at Catalonian public hospitals from 2011 to 2012. We obtained follow‐up data for up to 5 years. To minimize the differences between the two groups, we performed propensity score matching on baseline patient characteristics. We used multivariate Cox proportional hazards regression analyses to assess locoregional relapse at 2 years and death at 2 and 5 years.
Results
Of 1513 patients with Stage I–III rectal cancer, 933 (61.7%) had laparoscopy (conversion rate 13.2%). After applying our propensity score matching strategy (2:1), 842 laparoscopy patients were matched to 517 open surgery patients. Multivariate Cox analysis of death at 2 years hazard ratio (HR) 0.65, 95% CI 0.48, 0.87; P = 0.004 and 5 years (HR 0.61, 95% CI 0.5, 0.75; P < 0.001) and of local relapse at 2 years (HR 0.44, 95% CI 0.27, 0.72; P = 0.001) showed laparoscopy to be an independent protective factor compared with open surgery.
Conclusions
Laparoscopy results in lower locoregional relapse and long‐term mortality in rectal cancer in unselected patients with all‐risk groups included. Studies using long‐term follow‐up of cohorts and unselected data can provide information on clinically relevant outcomes to supplement randomized controlled trials.
Background
Laparoscopic cholecystectomy is one of the most common surgical procedures in Europe (and the world) and has become the standard procedure for the management of symptomatic cholelithiasis ...or acute cholecystitis in patients without specific contraindications. Bile duct injuries (BDI) are rare but serious complications that can occur during a laparoscopic cholecystectomy. Prevention and management of BDI has given rise to a host of publications but very few recommendations, especially in Europe.
Methods
A systematic research of the literature was performed. An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. Statements and recommendations were drafted after a consensus development conference in May 2011, followed by presentation and discussion at the annual congress of the EAES held in Torino in June 2011. Finally, full guidelines were consented and adopted by the expert panel via e-mail and web conference.
Results
A total of 1,765 publications were identified through the systematic literature search and additional submission by panellists; 671 publications were selected as potentially relevant. Only 46 publications fulfilled minimal methodological criteria to support Clinical Practice Guidelines recommendations. Because the level of evidence was low for most of the studies, most statements or recommendations had to be based on consensus of opinion among the panel members. A total of 15 statements and recommendations were developed covering the following topics: classification of injuries, epidemiology, prevention, diagnosis, and management of BDI.
Conclusions
Because BDI is a rare event, it is difficult to generate evidence for prevention, diagnosis, or the management of BDI from clinical studies. Nevertheless, the panel has formulated recommendations. Due to the currently limited evidence, a European registry should be considered to collect and analyze more valid data on BDI upon which recommendations can be based.
Hand-assisted laparoscopic surgery (HALS) represents a useful alternative to conventional laparoscopic surgery (LS). Its potential advantages--(a quicker, safer procedure and less need to convert to ...open surgery) are due to the recovery of tactile feedback. However, HALS requires the performance of a mini-laparotomy when surgery commences, and the wound is stretched and compressed throughout the procedure. In addition, it is associated with a more intense manipulation of the intraabdominal viscera. All of these factors increase the surgical trauma, it is not known whether HALS maintains the minimally invasive characteristics of conventional LS. Therefore, we set out to study the applicability, immediate clinical outcome, inflammatory response, and cost of HALS compared with conventional LS using colectomy as a model.
We performed a prospective randomized trial comparing laparoscopic-assisted colectomy with HAL colectomy. The aims of the study were to assess (a) perioperative features, including time, advantages, and conversion; (b) the patient's immediate clinical response, including recovery of bowel sounds, refeeding time, postoperative pain, local and general morbidity, and hospital stay; (c) the effect on the inflammatory response, using interleukin-6 (ILG) and C-reactive protein (CRP) measurements; (d) oncological issues, including intraoperative cytology and features of the specimen; and (d) the relative costs of the two procedures.
A total of 54 patients were enrolled in the study, 27 laparoscopic and 27 HALS. The operative times were similar, but HALS was associated with a far lower conversion rate--7% vs 23%. Immediate clinical outcomes, oncological features, and costs were similar for the two procedures, but HALS was associated with a significantly greater increase in IL6 and CRP than the conventional laparoscopic procedure.
This comparative study shows that HALS simplifies difficult intraoperative situations, reducing the need for conversion. Although it is a more aggressive procedure, HALS preserves the features of a minimally invasive approach, maintains all of the oncological features of conventional laparoscopic surgery, and does not increase the cost. HALS should therefore be considered as a useful adjunct when difficult situations arise during conventional laparoscopic colectomy.
Measuring health-related quality of life (QoL) after surgery is essential for decision making by patients, surgeons, and payers. The aim of this consensus conference was twofold. First, it was to ...determine for which diseases endoscopic surgery results in better postoperative QoL than open surgery. Second, it was to recommend QoL instruments for clinical research.
An expert panel selected 12 conditions in which QoL and endoscopic surgery are important. For each condition, studies comparing endoscopic and open surgery in terms of QoL were identified. The expert panel reached consensus on the relative benefits of endoscopic surgery and recommended generic and disease-specific QoL instruments for use in clinical research.
Randomized trials indicate that QoL improves earlier after endoscopic than open surgery for gastroesophageal reflux disease (GERD), cholecystolithiasis, colorectal cancer, inguinal hernia, obesity (gastric bypass), and uterine disorders that require hysterectomy. For spleen, prostate, malignant kidney, benign colorectal, and benign non-GERD esophageal diseases, evidence from nonrandomized trials supports the use of laparoscopic surgery. However, many studies failed to collect long-term results, used nonvalidated questionnaires, or measured QoL components only incompletely. The following QoL instruments can be recommended: for benign esophageal and gallbladder disease, the GIQLI or the QOLRAD together with SF-36 or the PGWB; for obesity surgery, the IWQOL-Lite with the SF-36; for colorectal cancer, the FACT-C or the EORTC QLQ-C30/CR38; for inguinal and renal surgery, the VAS for pain with the SF-36 (or the EORTC QLQ-C30 in case of malignancy); and after hysterectomy, the SF-36 together with an evaluation of urinary and sexual function.
Laparoscopic surgery provides better postoperative QoL in many clinical situations. Researchers would improve the quality of future studies by using validated QoL instruments such as those recommended here.
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