Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: the CLEAN study

Surg Endosc. 2018 Jan;32(1):315-327. doi: 10.1007/s00464-017-5679-6. Epub 2017 Jun 29.

Abstract

Introduction: Non-healing of anastomotic leakage can be observed in up to 50% after total mesorectal excision for rectal cancer. This study investigates the efficacy of early transanal closure of anastomotic leakage after pre-treatment with the Endosponge® therapy.

Methods: In this prospective, multicentre, feasibility study, transanal suturing of the anastomotic defect was performed after vacuum-assisted cleaning of the presacral cavity. Primary outcome was the proportion of patients with a healed anastomosis at 6 months after transanal closure. Secondary, healing at last follow-up, continuity, direct medical costs, functionality and quality of life were analysed.

Results: Between July 2013 and July 2015, 30 rectal cancer patients with a leaking low colorectal anastomosis were included, of whom 22 underwent neoadjuvant radiotherapy. Median follow-up was 14 (7-29) months. At 6 months, the anastomosis had healed in 16 (53%) patients. At last follow-up, anastomotic integrity was found in 21 (70%) and continuity was restored in 20 (67%) patients. Non-healing at 12 months was observed in 10/29 (34%) patients overall, and in 3/14 (21%) when therapy started within three weeks following the index operation. Major LARS was reported in 12/15 (80%) patients. The direct medical costs were €8933 (95% CI 7268-10,707) per patient.

Conclusion: Vacuum-assisted early transanal closure of a leaking anastomosis after total mesorectal excision with 73% preoperative radiotherapy showed that acceptable anastomotic healing rates and stoma reversal rates can be achieved. Early diagnosis and start of treatment seems crucial.

Keywords: Anastomotic leakage; Rectal cancer; Transanal closure; Vacuum therapy.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anastomosis, Surgical / adverse effects
  • Anastomotic Leak / surgery*
  • Colon / surgery*
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Negative-Pressure Wound Therapy / methods*
  • Neoadjuvant Therapy
  • Prospective Studies
  • Quality of Life
  • Radiotherapy, Adjuvant
  • Rectal Neoplasms / radiotherapy
  • Rectal Neoplasms / surgery*
  • Rectum / surgery*
  • Suture Techniques*

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