Rectal CarcinomaPhase 3NCT02770911
Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
A Phase 3 study testing without "Dog Ear" group and with "Dog Ear" group in people with Rectal Carcinoma and Laparoscopy, run by Fujian Medical University.
Trial summary
The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Carcinoma, Laparoscopy, Anastomotic Leak
- What is being tested?
- without "Dog Ear" group and with "Dog Ear" group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility rule of enrollment
- Rectal adenocarcinoma above the peritoneal reflection
- at least 18 years old \& at most 80 years old
- Clinically diagnosed cT1-T4aN0-2 disease
- no contraindication to laparoscopic surgery
- without other malignancies in medical history
Who cannot join
- concurrent or previous diagnosis of invasive cancer within 5 years
- locally advanced cancers requiring en bloc multivisceral resection
- intestinal obstruction
- intestinal perforation
- American Society of Anesthesiologists(ASA) class 4 or 5
- pregnant or breast-feeding women
- history of mental disorder
- participation in another rectal cancer clinical trial relating to surgical technique
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.
Read the detailed description
Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.
- Conditions
- Rectal Carcinoma, Laparoscopy, Anastomotic Leak
- Being tested
- without "Dog Ear" group, with "Dog Ear" group
- Keywords
- Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without "Dog Ear" groupProcedure or surgery
Also called modified laparoscopic double-stapled anastomosis
a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
with "Dog Ear" groupProcedure or surgery
Also called traditional laparoscopic double-stapled anastomosis
a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection
| Study group | Role | What they receive |
|---|---|---|
| without "Dog Ear" group | Experimental | Before anastomosis, the surgeon made a laparoscopic suturing on the two dog ears by using 3-0 monofilament sutures, and pull two dogears of staple line around the trocar by a tied suture through two dog ears. By this way, the staple line was kept within the circular knife when the circular stapler was closed. Then a true end-to-end anastomosis was performed after stapler firing. Receives: Procedure: without "Dog Ear" group |
| with "Dog Ear" group | Active comparator | traditional double-stapled anastomosis was used for laparoscopic anterior resection Receives: Procedure: with "Dog Ear" group |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leakage rate
Measured: 30 days since the date of surgery
Secondary outcomes (5)
Intra-operative and post-operative complications
Measured: 30 days since the date of surgery
post-operative Mortality
Measured: 30 days since the date of surgery
re-operation rate
Measured: 30 days since the date of surgery
QLQ 30
Measured: at postoperative 3,6 and 12 months
Wexner's scoring
Measured: at postoperative 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxian Guan, Fujian Medical University
- Investigators
- Guo-xian Guan, MD,PhD, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770911
- Sponsor's protocol ID
- FJMU-20160424
- Status last verified
- May 2016
- First submitted
- 8 May 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roumen 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 10789750Kang J, Lee HB, Cha JH, Hur H, Min BS, Baik SH, Kim NK, Sohn SK, Lee KY. Feasibility and impact on surgical outcomes of modified double-stapling technique for patients undergoing laparoscopic anterior resection. J Gastrointest Surg. 2013 Apr;17(4):771-5. doi: 10.1007/s11605-012-2122-0. Epub 2013 Jan 4.
PubMed 23288715Kim HJ, Choi GS, Park JS, Park SY. Comparison of intracorporeal single-stapled and double-stapled anastomosis in laparoscopic low anterior resection for rectal cancer: a case-control study. Int J Colorectal Dis. 2013 Jan;28(1):149-56. doi: 10.1007/s00384-012-1582-8. Epub 2012 Sep 27.
PubMed 23014975Chen ZF, Liu X, Jiang WZ, Guan GX. Laparoscopic double-stapled colorectal anastomosis without "dog-ears". Tech Coloproctol. 2016 Apr;20(4):243-7. doi: 10.1007/s10151-016-1437-3. Epub 2016 Feb 22. No abstract available.
PubMed 26902367Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
PubMed 20004450
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02770911
- Acronym / sponsor ID
- FJMU-20160424
- Conditions
- Rectal Carcinoma, Laparoscopy, Anastomotic Leak
- Keywords
- Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 12 May 2016 (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 study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.
Detailed description
Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without "Dog Ear" group | Experimental | Procedure: without "Dog Ear" groupBefore anastomosis, the surgeon made a laparoscopic suturing on the two dog ears by using 3-0 monofilament sutures, and pull two dogears of staple line around the trocar by a tied suture through two dog ears. By this way, the staple line was kept within the circular knife when the circular stapler was closed. Then a true end-to-end anastomosis was performed after stapler firing. |
| with "Dog Ear" group | Active comparator | Procedure: with "Dog Ear" grouptraditional double-stapled anastomosis was used for laparoscopic anterior resection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligibility rule of enrollment
- Rectal adenocarcinoma above the peritoneal reflection
- at least 18 years old \& at most 80 years old
- Clinically diagnosed cT1-T4aN0-2 disease
- no contraindication to laparoscopic surgery
Key exclusion criteria (8 listed)
- concurrent or previous diagnosis of invasive cancer within 5 years
- locally advanced cancers requiring en bloc multivisceral resection
- intestinal obstruction
- intestinal perforation
- American Society of Anesthesiologists(ASA) class 4 or 5
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 |
|---|---|---|
| without "Dog Ear" groupAlso: modified laparoscopic double-stapled anastomosisa modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection | Procedure or surgery | without "Dog Ear" group |
| with "Dog Ear" groupAlso: traditional laparoscopic double-stapled anastomosisa traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection | Procedure or surgery | with "Dog Ear" group |
Primary outcome
anastomotic leakage rate
Time frame: 30 days since the date of surgery
5 secondary outcomes
Intra-operative and post-operative complications
Time frame: 30 days since the date of surgery
post-operative Mortality
Time frame: 30 days since the date of surgery
re-operation rate
Time frame: 30 days since the date of surgery
QLQ 30
Time frame: at postoperative 3,6 and 12 months
Wexner's scoring
Time frame: at postoperative 3,6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Results publication: 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.
- Results publication: PubMed 23288715Kang J, Lee HB, Cha JH, Hur H, Min BS, Baik SH, Kim NK, Sohn SK, Lee KY. Feasibility and impact on surgical outcomes of modified double-stapling technique for patients undergoing laparoscopic anterior resection. J Gastrointest Surg. 2013 Apr;17(4):771-5. doi: 10.1007/s11605-012-2122-0. Epub 2013 Jan 4.
- Results publication: PubMed 23014975Kim HJ, Choi GS, Park JS, Park SY. Comparison of intracorporeal single-stapled and double-stapled anastomosis in laparoscopic low anterior resection for rectal cancer: a case-control study. Int J Colorectal Dis. 2013 Jan;28(1):149-56. doi: 10.1007/s00384-012-1582-8. Epub 2012 Sep 27.
- Results publication: PubMed 26902367Chen ZF, Liu X, Jiang WZ, Guan GX. Laparoscopic double-stapled colorectal anastomosis without "dog-ears". Tech Coloproctol. 2016 Apr;20(4):243-7. doi: 10.1007/s10151-016-1437-3. Epub 2016 Feb 22. No abstract available.
- Results publication: PubMed 20004450Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
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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.
Guo-xian Guan, MD,PhD principal investigator
Fujian Medical University Union Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing without "Dog Ear" group and with "Dog Ear" group in people with Rectal Carcinoma and Laparoscopy, run by Fujian Medical University.
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 8 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Guo-xian Guan, MD,PhD (86-13609592321, gxguan1108@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leakage 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 NCT02770911, which also lists 5 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 12 May 2016.