Evidence map›Paper›PMID 26525206›Full record

Trial reportJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2016

Single-Layer Continuous Versus Double-Layer Continuous Suture in Colonic Anastomoses-a Randomized Multicentre Trial (ANATECH Trial).

F Herrle, M K Diener, S Freudenberg, F Willeke, P Kienle, R Boenninghoff, C Weiss, L I Partecke, J Schuld, S Post

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00996554 (Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00996554 phase3terminatednot on this map

Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous

TypeinterventionalSponsorUniversitätsmedizin MannheimRan2004 to 2012Enrolled252ConditionsColo-colonic Anastomoses, Ileo-colonic AnastomosesArmsdouble layer-suture, Single-layer suture
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Systematic Review and Meta-Analysis on Colorectal Anastomotic Techniques.Therapeutics and clinical risk management · 2022
    Review
  5. Review
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 2 countries.

F HerrleSurgical Department of the University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
M K DienerStudy Centre of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 672, 69120, Heidelberg, Germany.
S FreudenbergDepartment of General, Visceral and Vascular Surgery, Helios Hospital, An der Gontardslust 7, 57319, Bad Berleburg, Germany.
F WillekeDepartment of Surgery, St. Marien Hospital, Kampenstr. 51, 57072, Siegen, Germany.
P KienleSurgical Department of the University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
R BoenninghoffDepartment of General, Visceral and Vascular Surgery, St. Josefs Hospital, Landhausstr. 25, 69115, Heidelberg, Germany.
C WeissDepartment of Medical Statistics, Biometry and Informatics, Medical Faculty Mannheim, University of Heidelberg, Ludolf-Krehl-Straße 13-17, 68167, Mannheim, Germany.
L I ParteckeDepartment of General, Visceral, Thoracic and Vascular Surgery, University Medical Centre Greifswald, University of Greifswald, Ferdinand-Sauerbruch-Straße, 17475, Greifswald, Germany.
J SchuldDepartment of General Visceral Vascular and Pediatric Surgery, University of Saarland, Homburg/Saar, Germany.
S PostSurgical Department of the University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. stefan.post@umm.de.
Heidelberg University · DEGerman Society of Surgery · DEHelios Hospital Schwerin · DESaarland University · DESt. Josefs Hospital · DESt. Marien Hospital · DEUniversitätsmedizin Greifswald · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeApart from stapling methods, single- or double-layer continuous hand sutures are established techniques for colonic anastomoses. It is unclear which hand suture technique has superior anastomotic safety. This randomized trial evaluated the incidence of postoperative complications depending on anastomosis technique.

methodsThis multicentre randomized trial enrolled adult elective patients between February 2004 and June 2012 in four German university hospitals. Primary endpoint was incidence of clinical anastomotic leakage until 3 months postoperatively. Estimated sample size was 768 randomized patients. Main secondary endpoints were duration of anastomotic suture, postoperative morbidity and stool patterns at 3-month follow-up. Patients and postoperative outcome assessors were blinded to the group assignment. This trial is registered (NCT00996554).

resultsDue to slow recruitment, the trial was stopped prematurely. Two hundred fifty-two patients (129 to single-layer suture anastomosis (SLA), 123 to double-layer suture anastomosis (DLA)) were randomized and analysed. Nine patients (3.6 %) were lost during follow-up. Exploratory primary endpoint analysis by intention-to-treat principle showed no significant difference for clinical anastomotic leakage between suturing techniques (SLA, 4 of 129 (3.1 %) vs. DLA, 6 of 123 (4.9 %), p = 0.532). Secondary endpoint analysis showed on average a 6-min shorter suture duration for SLA than DLA (18 min (4-49) vs. 24 min (8-50), p < 0.001). At 3-month follow-up, subjective well-being and stool patterns were not significantly different between groups.

conclusionsThe present study did not reach sufficient power and cannot confirm whether both techniques might be equally or if one technique might be superior. Exploratory analysis suggests that in elective colonic resections, the single-layer continuous hand suture technique may be equally effective as the double-layer technique regarding incidence of anastomotic leakage, length of hospital stay, overall postoperative complications, subjective short-term well-being and stool patterns. Lessons learned from this trial course are summarized.

trial registrationThis trial is registered (Trial registration: NCT00996554). Link: https://clinicaltrials.gov/ct2/show/NCT00996554 .

Indexed as

AdultAgedAnastomosis, SurgicalAnastomotic LeakColonElective Surgical ProceduresFemaleHumansIleumIncidenceLength of StayMaleMiddle AgedSuturesSuture TechniquesAnastomosis techniqueAnastomotic leakageColonic anastomosisColorectal surgery

Identifiers

PMID26525206
OpenAlexW1925469197

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.