Rectal NeoplasmsNCT02565667
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
A study testing KOL and traditional staple in people with Rectal Neoplasms, run by Fudan University at 1 site in China.
Trial summary
The most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- KOL and traditional staple
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological confirmed rectal adenocarcinoma
- less than 10 cm of distal tumor margin from the anal edge
- less than 4 cm of maximum tumor diameter and less than 1/2 of circumference diameter
- tumor stage earlier than cT1-3N0M0 before surgery or that following neoadjuvant radiochemotherapy
- normal defecation function (Wexner score < 4)
- open or laparoscopic operation
Who cannot join
- recurrent cases
- emergency including obstruction, bleeding or perforation
- severe abdominal adhesions
- severe malnutrition can not be improved before surgery
- can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney
- refractory hypoproteinemia or diabetes mellitus
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
SANJUN CAI, DOCTOR, 02164175590 ext. 1108, caisanjun@gmail.com
XINXIANG LI, DOCTOR
About this study
Official title: A Prospective Randomized Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
The most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.
Read the detailed description
About 5-10% of patients receiving low rectal resection using traditional anastomosis occurred anastomotic leak, risk factors for which included patient related (age, gender, tumor distance from the anal verge), hypoproteinemia, diabetes mellitus, etc), procedure related (emergency) and technical related (one stapler, double stapler or handsewn).
Anastomotic leak caused prolonged hospital stay, delayed post-operative adjuvant radiochemotherapy and need of stoma in some cases. Besides, anastomotic leak was reported to be associated with increased local recurrence rate. Thus, it's of great importance to develop new surgical devices to prevent "dog ear" problem and reduce the anastomotic leak rate.
Double stapled pursestring anastomosis was the one of the most widely used methods in lower rectal resection. One major problem of this procedure was creating one or double side "dog ear" phenomenon (Dis Colon Rectum. 2000 Apr;43(4):522-5. Fig 1). This weak spot was theoretically responsible for post-operative anastomotic leak as demonstrated by animal experiments and clinical practice.
In this clinical trial, we used a transanal double purse-string rectal anastomosis preformed with KOL stapler for lower rectal resection. This procedure would resolve the dog ear problem through circular anastomosis taking care that the anastomotic site contained only gut tissues without any staples. We aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.
- Conditions
- Rectal Neoplasms
- Being tested
- KOL, traditional staple
- Keywords
- low rectal carcinoma, anastomosis, anterior rectal resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOLDevice
KOL staple was used for rectal anastomosis
traditional stapleDevice
traditional staple was used for rectal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| KOL group | Experimental | KOL stapler was used for rectal anastomosis Receives: Device: KOL |
| traditional stapler group | Active comparator | traditional stapler was used for rectal anastomosis Receives: Device: traditional staple |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leak rate
percentage of patients occuring anastomotic leak within 30 days since surgery
Measured: 30 days since the date of surgery
Secondary outcomes (2)
post-operative anal function
Measured: within one year since the date of surgery
30-day mortality rate
Measured: within 30 days since the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI XIN-XIANG, Fudan University
- Investigators
- Li Xin-Xiang, M.D & Ph.D., Study director, Shanghai Cancer Center, Fudan University, #270 Dong An Road, Shanghai, 200030
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565667
- Sponsor's protocol ID
- FudanKOL
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2015
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Midura EF, Hanseman D, Davis BR, Atkinson SJ, Abbott DE, Shah SA, Paquette IM. Risk factors and consequences of anastomotic leak after colectomy: a national analysis. Dis Colon Rectum. 2015 Mar;58(3):333-8. doi: 10.1097/DCR.0000000000000249.
PubMed 25664712Espin E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26.
PubMed 25619499Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.
PubMed 22968068Morse BC, Simpson JP, Jones YR, Johnson BL, Knott BM, Kotrady JA. Determination of independent predictive factors for anastomotic leak: analysis of 682 intestinal anastomoses. Am J Surg. 2013 Dec;206(6):950-5; discussion 955-6. doi: 10.1016/j.amjsurg.2013.07.017. Epub 2013 Sep 24.
PubMed 24070663Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.
PubMed 21394013Roumen RM, Rahusen FT, Wijnen MH, Croiset van Uchelen FA. "Dog ear" formation after double-stapled low anterior resection as a risk factor for anastomotic disruption. Dis Colon Rectum. 2000 Apr;43(4):522-5. doi: 10.1007/BF02237198.
PubMed 10789750
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
- ClinicalTrials.gov ID
- NCT02565667
- Acronym / sponsor ID
- FudanKOL
- Conditions
- Rectal Neoplasms
- Keywords
- low rectal carcinoma, anastomosis, anterior rectal resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- 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 most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.
Detailed description
About 5-10% of patients receiving low rectal resection using traditional anastomosis occurred anastomotic leak, risk factors for which included patient related (age, gender, tumor distance from the anal verge), hypoproteinemia, diabetes mellitus, etc), procedure related (emergency) and technical related (one stapler, double stapler or handsewn).
Anastomotic leak caused prolonged hospital stay, delayed post-operative adjuvant radiochemotherapy and need of stoma in some cases. Besides, anastomotic leak was reported to be associated with increased local recurrence rate. Thus, it's of great importance to develop new surgical devices to prevent "dog ear" problem and reduce the anastomotic leak rate.
Double stapled pursestring anastomosis was the one of the most widely used methods in lower rectal resection. One major problem of this procedure was creating one or double side "dog ear" phenomenon (Dis Colon Rectum. 2000 Apr;43(4):522-5. Fig 1). This weak spot was theoretically responsible for post-operative anastomotic leak as demonstrated by animal experiments and clinical practice.
In this clinical trial, we used a transanal double purse-string rectal anastomosis preformed with KOL stapler for lower rectal resection. This procedure would resolve the dog ear problem through circular anastomosis taking care that the anastomotic site contained only gut tissues without any staples. We aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KOL group | Experimental | Device: KOLKOL stapler was used for rectal anastomosis |
| traditional stapler group | Active comparator | Device: traditional stapletraditional stapler was used for rectal anastomosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathological confirmed rectal adenocarcinoma
- less than 10 cm of distal tumor margin from the anal edge
- less than 4 cm of maximum tumor diameter and less than 1/2 of circumference diameter
- tumor stage earlier than cT1-3N0M0 before surgery or that following neoadjuvant radiochemotherapy
- normal defecation function (Wexner score < 4)
Key exclusion criteria (6 listed)
- recurrent cases
- emergency including obstruction, bleeding or perforation
- severe abdominal adhesions
- severe malnutrition can not be improved before surgery
- can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney
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 |
|---|---|---|
| KOLKOL staple was used for rectal anastomosis | Device | KOL group |
| traditional stapletraditional staple was used for rectal anastomosis | Device | traditional stapler group |
Primary outcome
anastomotic leak rate
Time frame: 30 days since the date of surgery
percentage of patients occuring anastomotic leak within 30 days since surgery
2 secondary outcomes
post-operative anal function
Time frame: within one year since the date of surgery
30-day mortality rate
Time frame: within 30 days since the date of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Background: PubMed 25664712Midura EF, Hanseman D, Davis BR, Atkinson SJ, Abbott DE, Shah SA, Paquette IM. Risk factors and consequences of anastomotic leak after colectomy: a national analysis. Dis Colon Rectum. 2015 Mar;58(3):333-8. doi: 10.1097/DCR.0000000000000249.
- Background: PubMed 25619499Espin E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26.
- Background: PubMed 22968068Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.
- Background: PubMed 24070663Morse BC, Simpson JP, Jones YR, Johnson BL, Knott BM, Kotrady JA. Determination of independent predictive factors for anastomotic leak: analysis of 682 intestinal anastomoses. Am J Surg. 2013 Dec;206(6):950-5; discussion 955-6. doi: 10.1016/j.amjsurg.2013.07.017. Epub 2013 Sep 24.
- Background: PubMed 21394013Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.
- Background: PubMed 10789750Roumen RM, Rahusen FT, Wijnen MH, Croiset van Uchelen FA. "Dog ear" formation after double-stapled low anterior resection as a risk factor for anastomotic disruption. Dis Colon Rectum. 2000 Apr;43(4):522-5. doi: 10.1007/BF02237198.
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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.
Li Xin-Xiang, M.D & Ph.D. study director
Shanghai Cancer Center, Fudan University, #270 Dong An Road, Shanghai, 200030
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOL and traditional staple in people with Rectal Neoplasms, run by Fudan University 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 6 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 Mar 2016. 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 Li Xin-Xiang, M.D & Ph.D. (+86-18017312900, lxx1149@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leak rate (time frame: 30 days since the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565667, which also lists 6 linked publications.
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 Mar 2016.