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Status unknownNCT03281070Updated Dec 28, 2017

Anastomotic Leakage After Anterior Resection of Rectal Cancer

An observational study in Rectal Cancer, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2017-12-28.

Sponsored by Beijing Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Rectal Neoplasms by Beijing Friendship Hospital — 7 open to participants now, 8 under way, none of them phase 3. Rectal Neoplasms · Beijing Friendship Hospital.

Started
2017
with 2 others
Observational
6 of 11
3 open now
Registered
2nd of 11
by date

Among the 11 studies in Rectal Neoplasms by Beijing Friendship Hospital, this one is one of 3 that started in 2017, is one of 6 observational ones, and was the 2nd registered.

Rectal Neoplasms

2,401 studies on the registry are indexed under Rectal Neoplasms; 588 are open to participants now.

Browse Rectal Neoplasms studies →

Open to participants now

7 of the 11 studies in Rectal Neoplasms by Beijing Friendship Hospital are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 404 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 142 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior resection of rectal cancer. This complication compromises both short term and long term outcome of patients. The incidence of AL after anterior resection was approximately 6-11%. Although several risk factors for AL such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of AL did not meet a significant decrease. So far there is no multi-site observational study on incidence and risk factors of AL after anterior resection in China, therefore this study aims to work on this issue and provide evidence for clinical practice.

03

Conditions studied

  • Rectal Cancer

Keywords

  • Anastomotic leakage
  • Anterior resection
  • Risk factors
  • Incidence
  • Rectal Cancer
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Rectal cancer patients who underwent anterior resection with or without postoperative anastomotic leakage

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adenocarcinoma of the rectum by
  • single lesion
  • anterior resection was performed
  • anastomosis using circular stapler

Exclusion criteria

Exclusion Criteria:

  • history of colorectal cancer surgery
  • emergency surgery because of bowel obstruction, bleeding or perforation
  • colo-anal anastomosis
  • subtotal colectomy
  • total colectomy
  • abdominal perineal resection
  • Hartmann procedure
  • pull out anastomosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Anastomotic leakage

    Anastomotic leakage is defined as a defect of the intestinal wall integrity at the colorectal anastomotic site leading to a communication between the intra- and extraluminal compartments.

    Time frame: 14 days after surgery

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital
    Beijing, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for May 2018, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 13, 2017
StartActual
Oct 1, 2017
Primary completionEst.
May 1, 2018
CompletionEst.
May 1, 2018
Last update
Dec 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03281070
Responsible party
Zhongtao Zhang (Department of General Surgery, Beijing Friendship Hospital) — Principal investigator
First posted
Sep 13, 2017
Start date
Oct 1, 2017
Primary completion
May 1, 2018 (estimated)
Completion
May 1, 2018 (estimated)
Last update
Dec 28, 2017

Study contacts

Hongwei Yao, M.D.
Contact
yaohongwei@medmail.com.cn
+8613611015609
Jun Li, M.D.
Contact
lijunsy2002@163.com
+8613811379656

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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