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

  • Original Article
  • Published:
Journal of Gastrointestinal Surgery Aims and scope

Abstract

Purpose

Apart 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.

Methods

This 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).

Results

Due 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.

Conclusions

The 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 Registration

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

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Acknowledgments

Christoph Seiler and Jens Werner provided strong and essential support for the initiation of the University Clinic Heidelberg as recruitment centre for the ANATECH trial.

ETHICON (Johnson & Johnson Medical GmbH, Norderstedt, Germany) provided suture material (PDS 4–0 and PDS 5–0) for both trial arms as unrestricted trial support; no other public or industrial funding or support were granted.

Author information

Authors and Affiliations

  1. Surgical Department of the University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany

    F. Herrle, P. Kienle & S. Post

  2. Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 672, 69120, Heidelberg, Germany

    M. K. Diener

  3. Department of Surgery, St. Marien Hospital, Kampenstr. 51, 57072, Siegen, Germany

    F. Willeke

  4. Department of Medical Statistics, Biometry and Informatics, Medical Faculty Mannheim, University of Heidelberg, Ludolf-Krehl-Straße 13-17, 68167, Mannheim, Germany

    C. Weiss

  5. Department of General, Visceral, Thoracic and Vascular Surgery, University Medical Centre Greifswald, University of Greifswald, Ferdinand-Sauerbruch-Straße, 17475, Greifswald, Germany

    L. I. Partecke

  6. Department of General Visceral Vascular and Pediatric Surgery, University of Saarland, Homburg/Saar, Germany

    J. Schuld

  7. Department of General, Visceral and Vascular Surgery, Helios Hospital, An der Gontardslust 7, 57319, Bad Berleburg, Germany

    S. Freudenberg

  8. Department of General, Visceral and Vascular Surgery, St. Josefs Hospital, Landhausstr. 25, 69115, Heidelberg, Germany

    R. Boenninghoff

Authors
  1. F. Herrle
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  2. M. K. Diener
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  3. S. Freudenberg
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  4. F. Willeke
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  5. P. Kienle
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  6. R. Boenninghoff
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  7. C. Weiss
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  8. L. I. Partecke
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  9. J. Schuld
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  10. S. Post
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Corresponding author

Correspondence to S. Post.

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Sources of Funding/Support

ETHICON (Johnson & Johnson Medical GmbH, Norderstedt, Germany) provided suture material (PDS 4–0 and PDS 5–0) for both trial arms as unrestricted trial support. No further external funding was available.

Previous Communication

An abstract version of trial results has been presented as oral short presentation at the 7th meeting of the German Society of General and Visceral Surgery (DGAV) on 12 Sept. 2013 in Nuremberg, Germany.

Disclosure Statement

Prof. Dr. Post, Prof. Dr. Kienle and Dr. Herrle from the University Medical Centre Mannheim, Germany report non-financial support from ETHICON (Johnson & Johnson Medical GmbH, Norderstedt, Germany) during the conduct of the study. ETHICON provided suture material (PDS-4-0 and PDS 5-0) for both trial arms as unrestricted trial support. No other external funding was granted.

Conflict of Interest

The authors declare that they have no competing interests.

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Herrle, F., Diener, M.K., Freudenberg, S. et al. Single-Layer Continuous Versus Double-Layer Continuous Suture in Colonic Anastomoses—a Randomized Multicentre Trial (ANATECH Trial). J Gastrointest Surg 20, 421–430 (2016). https://doi.org/10.1007/s11605-015-3003-0

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  • DOI: https://doi.org/10.1007/s11605-015-3003-0

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