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NCT Number: NCT07279961

A Multicenter Study on the Safety and Functionality Evaluation of Anastomotic Redo Surgery

To analyze the influencing factors of the success of redo surgery due to anastomotic fistula or anastomotic recurrence after rectal cancer surgery and to evaluate the anal function of patients

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

Redo surgery is a critical salvage strategy for anastomotic complications or local recurrence following rectal cancer resection. Despite technical feasibility, functional outcomes remain suboptimal. This study evaluated intestinal continuity restoration and anal function recovery after redo surgery, alongside prognostic factors influencing outcomes. A retrospective multicenter study analyzed 143 patients undergoing redo surgery (2015-2023) for anastomotic failure or local recurrence. Primary endpoints included anatomical restoration of intestinal continuity, while secondary endpoints assessed functional outcomes using the LARS score.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior curative resection for primary colorectal adenocarcinoma.
  • Subsequent reoperation for anastomotic failure or locoregional recurrence.
  • Absence of absolute contraindications to reoperative surgery.

Exclusion criteria

  • Primary tumors located proximal to the sigmoid colon.
  • Radiologically confirmed distant metastases.
  • Presence of a permanent stoma at the time of questionnaire administration.
  • Insufficient literacy or cognitive function to complete study-related -questionnaires.

Treatment and study plan

Primary outcomes

  1. Whether postoperative patients with rectal cancer can restore intestinal continuity, that is, defecate through the anus

    Time frame: During the follow-up period, at least two years after rectal cancer surgery

Secondary outcomes

  1. Low Anterior Rectal Syndrome (LARS) Score of patients restoring intestinal continuity

    Time frame: During the follow-up period, at least one year has passed since the intestinal continuity was restored

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Multicenter Retrospective Study in China: the Factors Influencing the Success of Redo Surgery and Anal Function for Anastomosis Failure or Local Tumor Recurrence

Important dates

Study start
2006
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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