Anastomotic LeakageNCT02718729
Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer
A study testing Laparoscopic resection for rectal cancer in people with Anastomotic Leakage, run by Mansoura University at 2 sites in 2 countries.
Trial summary
Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anastomotic Leakage
- What is being tested?
- Laparoscopic resection for rectal cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2015to 1 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who undergo laparoscopic resection for biopsy proven rectal cancer.
Who cannot join
- Open surgery,
- Emergency intervention,
- Palliative resection,
- Stage IV with distant metastasis,
- Recurrent cancer,
- Multivisceral resection
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily compromised blood supply.
Anastomotic leakage is the most feared complication following rectal resection and anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of patients.
Anastomotic leakage leads to increase the rate of secondary interventions, re-operations, longer postoperative hospital stay, increased cost, and major impact on the patient's quality of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself may increase the local recurrence, a reduction in overall survival, and a large proportion of patients are left with a permanent stoma.
Read the detailed description
Study populations: all patients will sign an informed consent prior to the surgery to be included in the study, after explanation of the nature of the disease, possible treatment, and the possibility of stoma formation.
Data recording: basic demographic data are recorded including age and sex of the patient as well as detailed information on history, risk factors, preoperative diagnostics, surgical procedure, intraoperative findings, histopathological work-up, and postoperative course.
Variables analysis: the variables are divided into patient-related, tumor-related, therapy-related, and techniques-related variables.
Preoperative workup: all patients will have detailed clinical history and physical examination including DRE. Routine laboratory investigations also are included e.g. CBC, blood glucose level, liver, and kidney function tests.
Regular workup for rectal cancer are included; full colonoscopy with biopsy, gastrografin/barium enema, TRUS evaluate degree of invasion of the rectal wall and regional lymph nodes, abdominal and pelvic CT scan, Chest x-ray or CT scan, CEA level, and EORTC Quality of life Questionnaire.
Level of the tumor: is measured from the lower border of the tumor to the anal verge by the rigid sigmoidoscope; considering it low < 6 cm, middle 6-12 cm, and upper > 12 cm.
Preoperative preparation: all patients will have preoperative mechanical bowel preparation and adequate thromboembolic prophylaxis. Prophylactic antibiotics will be given 30 - 60 minutes before surgery. A surgeon or stoma therapist will mark the site of the stoma before the operation in all patients.
Level of the anastomosis: is measured from the anastomosis to the anal verge by the rigid sigmoidoscope intraoperative; considering it low < 10 cm, middle 10-15 cm, and upper > 15 cm.
The rectal anastomosis is tested intraoperative with: trans-anal air insufflation with the pelvis immersed with saline to detect bubbles, trans-anal introduction of dye, or competence of donuts in stapled anastomosis.
Postoperative follow up:
Access the postoperative condition locally and systemically by bedsides clinical parameters, and usual blood tests like leucocyte count and CRP level at the 3rd and the 7th day postoperative.
Radiological follow up by Gastrografin enema around the 10th day or before dismissal from the hospital. Abdominal and pelvic CT scan is ordered in patients with clinical deterioration, abnormal abdominal findings, and turbid drainage secretion.
Peritoneal samples are collected from the abdominal drains at the first, third, and fifth days postoperatively for peritoneal microbiological study and cytokines (IL-6, IL-10, and TNF) level measurement.
Patients will receive a Quality of Life questionnaire (EORTC 30, 38) preoperatively, 30 days postoperative, and 30 days after stoma closure in case of diversion.
Follow up of patients continue till discharge, and 30 days postoperative. In cases with diversion follow up will continue till closure of stoma and 30 days after closure. Stoma closure in an uneventful course will be scheduled 8-10 weeks after the primary operation.
Diagnosis of leakage:
- Fecal secretion via indwelling abdominal drainage, surgical wound or vagina.
- Radiological via fluid collection adjacent to anastomosis associated with extraluminal contrast extravasation.
Classification of leakage: patients classified according to leakage into:
- Non leakage group.
- Leakage group, radiological is asymptomatic and detected on imaging, localized is diagnosed on radiological findings of a pelvic collection and clinically do not require a laparotomy or laparoscopy, and generalized is confirmed at laparotomy or laparoscopy.
Outcomes:
Primary outcomes:
Incidences of anastomotic leakage following laparoscopic resection for rectal cancer.
30 day's postoperative morbidity and mortality. secondary outcomes: The role of diversion on prevention of anastomotic leakage, are patients with diversion have low incidences of leakage.
Management of anastomotic leakage. Effect of anastomotic leakage on oncological outcome, assessment of local recurrence after 24 months follow-up.
- Conditions
- Anastomotic Leakage
- Being tested
- Laparoscopic resection for rectal cancer
- Keywords
- Anastomotic leakage, Rectal cancer, Laparoscopic, Rectal resection
- Medical subject headings
- Anastomotic Leak, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic resection for rectal cancerProcedure or surgery
Formal curative radical laparoscopic rectal resection.
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer patients | Other | All patients who will fulfill the inclusions criteria. Patients will undergo formal curative radical Laparoscopic resection for rectal cancer Receives: Procedure: Laparoscopic resection for rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anastomotic leakage
Incidence of anastomotic leakage in patients who underwent laparoscopic resection of rectal cancer. This including clinical and sub-clinical (radiological diagnosis) leakage.
Measured: 2 years
Secondary outcomes (4)
Role of diversion in prevention of anastomotic leakage.
Do the patients with diversion have low incidences of anastomotic leakage compared to those without.
Measured: 2 years
Management of anastomotic leakage
The comparison of conservative, radio-logical, or surgical options.
Measured: 2 years
Oncological outcomes of anastomotic leakage
For patients who complete 24 months of follow-up for local recurrence.
Measured: 2 years
30 days postoperative morbidity and mortality
In the first 30 days postoperative
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start1 Jun 2015
- Primary completion1 Jan 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakageStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Responsible party
- Principal investigator, Mostafa shalaby, MD, MSc, PhD, Mansoura University
- Investigators
- Mostafa Shalaby, M,D., MSc., Principal investigator, Mansoura University/ University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718729
- Sponsor's protocol ID
- MD 84
- Status last verified
- May 2020
- First submitted
- 12 Mar 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT02718729
- Acronym / sponsor ID
- MD 84
- Conditions
- Anastomotic Leakage
- Keywords
- Anastomotic leakage, Rectal cancer, Laparoscopic, Rectal resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 24 Mar 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.
Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily compromised blood supply.
Anastomotic leakage is the most feared complication following rectal resection and anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of patients.
Anastomotic leakage leads to increase the rate of secondary interventions, re-operations, longer postoperative hospital stay, increased cost, and major impact on the patient's quality of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself may increase the local recurrence, a reduction in overall survival, and a large proportion of patients are left with a permanent stoma.
Detailed description
Study populations: all patients will sign an informed consent prior to the surgery to be included in the study, after explanation of the nature of the disease, possible treatment, and the possibility of stoma formation.
Data recording: basic demographic data are recorded including age and sex of the patient as well as detailed information on history, risk factors, preoperative diagnostics, surgical procedure, intraoperative findings, histopathological work-up, and postoperative course.
Variables analysis: the variables are divided into patient-related, tumor-related, therapy-related, and techniques-related variables.
Preoperative workup: all patients will have detailed clinical history and physical examination including DRE. Routine laboratory investigations also are included e.g. CBC, blood glucose level, liver, and kidney function tests.
Regular workup for rectal cancer are included; full colonoscopy with biopsy, gastrografin/barium enema, TRUS evaluate degree of invasion of the rectal wall and regional lymph nodes, abdominal and pelvic CT scan, Chest x-ray or CT scan, CEA level, and EORTC Quality of life Questionnaire.
Level of the tumor: is measured from the lower border of the tumor to the anal verge by the rigid sigmoidoscope; considering it low < 6 cm, middle 6-12 cm, and upper > 12 cm.
Preoperative preparation: all patients will have preoperative mechanical bowel preparation and adequate thromboembolic prophylaxis. Prophylactic antibiotics will be given 30 - 60 minutes before surgery. A surgeon or stoma therapist will mark the site of the stoma before the operation in all patients.
Level of the anastomosis: is measured from the anastomosis to the anal verge by the rigid sigmoidoscope intraoperative; considering it low < 10 cm, middle 10-15 cm, and upper > 15 cm.
The rectal anastomosis is tested intraoperative with: trans-anal air insufflation with the pelvis immersed with saline to detect bubbles, trans-anal introduction of dye, or competence of donuts in stapled anastomosis.
Postoperative follow up:
Access the postoperative condition locally and systemically by bedsides clinical parameters, and usual blood tests like leucocyte count and CRP level at the 3rd and the 7th day postoperative.
Radiological follow up by Gastrografin enema around the 10th day or before dismissal from the hospital. Abdominal and pelvic CT scan is ordered in patients with clinical deterioration, abnormal abdominal findings, and turbid drainage secretion.
Peritoneal samples are collected from the abdominal drains at the first, third, and fifth days postoperatively for peritoneal microbiological study and cytokines (IL-6, IL-10, and TNF) level measurement.
Patients will receive a Quality of Life questionnaire (EORTC 30, 38) preoperatively, 30 days postoperative, and 30 days after stoma closure in case of diversion.
Follow up of patients continue till discharge, and 30 days postoperative. In cases with diversion follow up will continue till closure of stoma and 30 days after closure. Stoma closure in an uneventful course will be scheduled 8-10 weeks after the primary operation.
Diagnosis of leakage:
- Fecal secretion via indwelling abdominal drainage, surgical wound or vagina.
- Radiological via fluid collection adjacent to anastomosis associated with extraluminal contrast extravasation.
Classification of leakage: patients classified according to leakage into:
- Non leakage group.
- Leakage group, radiological is asymptomatic and detected on imaging, localized is diagnosed on radiological findings of a pelvic collection and clinically do not require a laparotomy or laparoscopy, and generalized is confirmed at laparotomy or laparoscopy.
Outcomes:
Primary outcomes:
Incidences of anastomotic leakage following laparoscopic resection for rectal cancer.
30 day's postoperative morbidity and mortality. secondary outcomes: The role of diversion on prevention of anastomotic leakage, are patients with diversion have low incidences of leakage.
Management of anastomotic leakage. Effect of anastomotic leakage on oncological outcome, assessment of local recurrence after 24 months follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer patients | Other | Procedure: Laparoscopic resection for rectal cancerAll patients who will fulfill the inclusions criteria. Patients will undergo formal curative radical Laparoscopic resection for rectal cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who undergo laparoscopic resection for biopsy proven rectal cancer.
Key exclusion criteria (6 listed)
- Open surgery,
- Emergency intervention,
- Palliative resection,
- Stage IV with distant metastasis,
- Recurrent cancer,
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 |
|---|---|---|
| Laparoscopic resection for rectal cancerFormal curative radical laparoscopic rectal resection. | Procedure or surgery | Rectal cancer patients |
Primary outcome
Incidence of anastomotic leakage
Time frame: 2 years
Incidence of anastomotic leakage in patients who underwent laparoscopic resection of rectal cancer. This including clinical and sub-clinical (radiological diagnosis) leakage.
4 secondary outcomes
Role of diversion in prevention of anastomotic leakage.
Time frame: 2 years
Management of anastomotic leakage
Time frame: 2 years
Oncological outcomes of anastomotic leakage
Time frame: 2 years
30 days postoperative morbidity and mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Anastomotic Leakage
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Anastomotic Leaks
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.
Mostafa Shalaby, M,D., MSc. principal investigator
Mansoura University/ University of Rome Tor Vergata
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic resection for rectal cancer in people with Anastomotic Leakage, run by Mansoura University at 2 sites in 2 countries.
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 1 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: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anastomotic leakage (time frame: 2 years). 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 29 May 2020.