Ulcerative ColitisNCT03536988
TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis
A study testing TAMIS-IPAA and Lap-IPAA in people with Ulcerative Colitis and Postoperative Complications, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis, Postoperative Complications, Ileal Pouch
- What is being tested?
- TAMIS-IPAA and Lap-IPAA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210000
Jianfeng Gong, MD, +86-25-80860036, gongjianfeng@aliyun.com
About this study
Official title: Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Ulcerative Colitis, Postoperative Complications, Ileal Pouch
- Being tested
- TAMIS-IPAA, Lap-IPAA
- Keywords
- Ulcerative Colitiis, Ileal pouch anal anastomosis, Transanal Minimally Invasive Surgery, Postoperative Outcome
- Medical subject headings
- Colitis, Ulcerative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAMIS-IPAAProcedure or surgery
In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
Lap-IPAAProcedure or surgery
In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.
| Study group | Role | What they receive |
|---|---|---|
| TAMIS-IPAA | Experimental | In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed. Receives: Procedure: TAMIS-IPAA |
| Lap-IPAA | Active comparator | In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed. Receives: Procedure: Lap-IPAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications
Postoperative complcations were documented using comprehensive complication index(CCI)
Measured: Day 30
Secondary outcomes (11)
Duration of operation
The duration of operation will be documented in minutes, from skin incision to dress coverage
Measured: 24 Hr
The incidence of pouch extension
the need to extend the length of pouch during operation
Measured: 24 Hr
Intraoperative complications
Including anastomotic burst, iatrogenic injury
Measured: 24 Hr
Estimated blood loss
in mLs during surgery
Measured: 24 Hr
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.
Measured: Day 90
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.
Measured: Day 90
Postoperative length of hospital stay
in days
Measured: Day 90
Overall cost of treatment
In Chinese Yuan (CNY)
Measured: up to 1 year
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.
Measured: 24 Hr
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.
Measured: up to 1 year
Postoperative quality of life
Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start12 Apr 2018
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Jianfeng Gong, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536988
- Sponsor's protocol ID
- JinlingH TAMIS
- Status last verified
- Jan 2018
- First submitted
- 15 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03536988
- Acronym / sponsor ID
- JinlingH TAMIS
- Conditions
- Ulcerative Colitis, Postoperative Complications, Ileal Pouch
- Keywords
- Ulcerative Colitiis, Ileal pouch anal anastomosis, Transanal Minimally Invasive Surgery, Postoperative Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAMIS-IPAA | Experimental | Procedure: TAMIS-IPAAIn TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed. |
| Lap-IPAA | Active comparator | Procedure: Lap-IPAAIn Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAMIS-IPAAIn TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed. | Procedure or surgery | TAMIS-IPAA |
| Lap-IPAAIn Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed. | Procedure or surgery | Lap-IPAA |
Primary outcome
Postoperative Complications
Time frame: Day 30
Postoperative complcations were documented using comprehensive complication index(CCI)
11 secondary outcomes
Duration of operation
Time frame: 24 Hr
The incidence of pouch extension
Time frame: 24 Hr
Intraoperative complications
Time frame: 24 Hr
Estimated blood loss
Time frame: 24 Hr
Postoperative anastmotic leakage
Time frame: Day 90
Time to GI-2 recovery
Time frame: Day 90
Postoperative length of hospital stay
Time frame: Day 90
Overall cost of treatment
Time frame: up to 1 year
Remaining length of anal mucosa.
Time frame: 24 Hr
The incidence of cuffitis and pouchitis
Time frame: up to 1 year
Postoperative quality of life
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfeng Gong principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAMIS-IPAA and Lap-IPAA in people with Ulcerative Colitis and Postoperative Complications, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Gong, MD (+86-25-80860036, gongjianfeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complications (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.