NCT03536988

Brief Summary

The objective of this RCT is to compare the postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 25, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

May 15, 2018

Last Update Submit

May 15, 2018

Conditions

Ulcerative ColitisPostoperative ComplicationsIleal Pouch

Keywords

Ulcerative ColitiisIleal pouch anal anastomosisTransanal Minimally Invasive SurgeryPostoperative Outcome

Outcome Measures

Primary Outcomes (1)

  • Postoperative Complications

    Postoperative complcations were documented using comprehensive complication index(CCI)

    Day 30

Secondary Outcomes (11)

  • Duration of operation

    24 Hr

  • The incidence of pouch extension

    24 Hr

  • Intraoperative complications

    24 Hr

  • Estimated blood loss

    24 Hr

  • Postoperative anastmotic leakage

    Day 90

  • +6 more secondary outcomes

Study Arms (2)

TAMIS-IPAA

EXPERIMENTAL

In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.

Procedure: TAMIS-IPAA

Lap-IPAA

ACTIVE COMPARATOR

In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.

Procedure: Lap-IPAA

Interventions

TAMIS-IPAAPROCEDURE

In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.

TAMIS-IPAA
Lap-IPAAPROCEDURE

In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.

Lap-IPAA

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clincially and pathologically proven ulcerative colitis
  • Aged 18-75 years
  • Patients who will undergo proctectomy and IPAA surgery, incuding the first stage of two-stage surgery, or the second stage of three-stage or modified two-stage surgery
  • Elective surgery
  • Informed constent obtained.

You may not qualify if:

  • A contraindication for minimally invasive surgery or TAMIS surgery
  • Ileus or peritonitis
  • Previous surgery in rectum
  • Pregnancy
  • Carcinogenesis of rectum, dysplasia or stricture of ATZ, or planned mucosectomy
  • Patients with planned permnant ileostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Colitis, UlcerativePostoperative Complications

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jianfeng Gong

    Jinling Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianfeng Gong, MD

CONTACT

+86-25-80860036gongjianfeng@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

April 12, 2018

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

May 25, 2018

Record last verified: 2018-01

Locations

CN(1)