Back to resultsTAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis
Primary Purpose
Ulcerative Colitis, Postoperative Complications, Ileal Pouch
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TAMIS-IPAA
Lap-IPAA
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitiis, Ileal pouch anal anastomosis, Transanal Minimally Invasive Surgery, Postoperative Outcome
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TAMIS-IPAA
Lap-IPAA
Arm Description
In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.
In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.
Outcomes
Primary Outcome Measures
Postoperative Complications
Postoperative complcations were documented using comprehensive complication index(CCI)
Secondary Outcome Measures
Duration of operation
The duration of operation will be documented in minutes, from skin incision to dress coverage
The incidence of pouch extension
the need to extend the length of pouch during operation
Intraoperative complications
Including anastomotic burst, iatrogenic injury
Estimated blood loss
in mLs during surgery
Postoperative anastmotic leakage
Anastomotic leakage was defined as any defect at the anastomotic site confirmed by imaging or during surgical re-intervention, and was categorised according to the impact on clinical management [A, B, C]. Grade A leaks had minimal to no clinical impact on the patient's postoperative course, requiring antibiotics at the most. Grade B leaks required active intervention such as radiological placement of a pelvic drain or transanal lavage. Grade C leaks required re-operation, mostly because the patient was not defunctioned.
Time to GI-2 recovery
Time to GI-2 recovery, a composite end point of the later of upper (first toleration of solid food) and lower (first bowel movement) GI function.
Postoperative length of hospital stay
in days
Overall cost of treatment
In Chinese Yuan (CNY)
Remaining length of anal mucosa.
The mean lenght of four quadrant during pouchoscopy 2 months after opertion, the length was calculated from the dental line to the anastomotic site.
The incidence of cuffitis and pouchitis
Pouchitis is defined as inflammatory condition of the ileal pouch reservoir, while cuffitis is defined as the inflammatory condition of the remnant rectal cuff.
Postoperative quality of life
Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03536988
Brief Title
TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis
Official Title
Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Theoritically, the advantge of TAMIS surgery over traditional trans-abdominal IPAA surgery incudes shorter operation time due to simulatous surgery transanlly and transabdominally, reduced operative difficulty in narrow male pelvis, less retained rectal cuff and less "dog-ear" formation. However, its adgange has not been proven in prospecitve randomized trials. The aim of current study is to compare the short and long-term postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Postoperative Complications, Ileal Pouch
Keywords
Ulcerative Colitiis, Ileal pouch anal anastomosis, Transanal Minimally Invasive Surgery, Postoperative Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAMIS-IPAA
Arm Type
Experimental
Arm Description
In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.
Arm Title
Lap-IPAA
Arm Type
Active Comparator
Arm Description
In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.
Intervention Type
Procedure
Intervention Name(s)
TAMIS-IPAA
Intervention Description
In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
Intervention Type
Procedure
Intervention Name(s)
Lap-IPAA
Intervention Description
In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.
Primary Outcome Measure Information:
Title
Postoperative Complications
Description
Postoperative complcations were documented using comprehensive complication index(CCI)
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Duration of operation
Description
The duration of operation will be documented in minutes, from skin incision to dress coverage
Time Frame
24 Hr
Title
The incidence of pouch extension
Description
the need to extend the length of pouch during operation
Time Frame
24 Hr
Title
Intraoperative complications
Description
Including anastomotic burst, iatrogenic injury
Time Frame
24 Hr
Title
Estimated blood loss
Description
in mLs during surgery
Time Frame
24 Hr
Title
Postoperative anastmotic leakage
Description
Anastomotic leakage was defined as any defect at the anastomotic site confirmed by imaging or during surgical re-intervention, and was categorised according to the impact on clinical management [A, B, C]. Grade A leaks had minimal to no clinical impact on the patient's postoperative course, requiring antibiotics at the most. Grade B leaks required active intervention such as radiological placement of a pelvic drain or transanal lavage. Grade C leaks required re-operation, mostly because the patient was not defunctioned.
Time Frame
Day 90
Title
Time to GI-2 recovery
Description
Time to GI-2 recovery, a composite end point of the later of upper (first toleration of solid food) and lower (first bowel movement) GI function.
Time Frame
Day 90
Title
Postoperative length of hospital stay
Description
in days
Time Frame
Day 90
Title
Overall cost of treatment
Description
In Chinese Yuan (CNY)
Time Frame
up to 1 year
Title
Remaining length of anal mucosa.
Description
The mean lenght of four quadrant during pouchoscopy 2 months after opertion, the length was calculated from the dental line to the anastomotic site.
Time Frame
24 Hr
Title
The incidence of cuffitis and pouchitis
Description
Pouchitis is defined as inflammatory condition of the ileal pouch reservoir, while cuffitis is defined as the inflammatory condition of the remnant rectal cuff.
Time Frame
up to 1 year
Title
Postoperative quality of life
Description
Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Gong, MD
Phone
+86-25-80860036
Email
gongjianfeng@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Gong
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Gong, MD
Phone
+86-25-80860036
Email
gongjianfeng@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis
We'll reach out to this number within 24 hrs