Mechanical Complication of Peritoneal Dialysis CatheterNCT02879734
Prophylactic Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheter
A study testing Prophylactic laparoscopic omentopexy in people with Mechanical Complication of Peritoneal Dialysis Catheter, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to compare function of the peritoneal dialysis catheter in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mechanical Complication of Peritoneal Dialysis Catheter
- What is being tested?
- Prophylactic laparoscopic omentopexy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Aug 2016to Jul 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
- End-stage renal failure in need of prolonged dialysis referred for insertion of peritoneal dialysis catheter
Who cannot join
- Contraindications to laparoscopic surgery
- Coagulative disorder
- Death of participant due to other reasons before usage of peritoneal catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Performing Prophylactic Omentopexy and Lack of Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheters in Terms of Complications and Catheter Function
The purpose of this study is to compare function of the peritoneal dialysis catheter in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.
Read the detailed description
Peritoneal dialysis is a know and accepted treatment in patients with end stage renal diseases. The is a safe, easy and cheap treatment modality in these patients. After introduction and development of laparoscopic procedures for insertion of peritoneal dialysis catheters, some prophylactic surgical techniques have been proposed as measures to reduce catheter malfunction. Omentopexy is among these techniques. The purpose of this study is to compare function of the peritoneal dialysis catheter (including inflow and outflow failure) in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.
- Being tested
- Prophylactic laparoscopic omentopexy
- Keywords
- peritoneal dialysis, laparoscopy, omentum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic laparoscopic omentopexyOther
Fixation of omentum with sutures to anterior abdominal wall during laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Without Omentopexy | No intervention | Patients that did not undergo prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter |
| With Omentopexy | Experimental | Patients that underwent prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter. Intervention = Prophylactic laparoscopic omentopexy Receives: Other: Prophylactic laparoscopic omentopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the peritoneal catheter to pass the dialysis fluid
Inflow and outflow passage of the peritoneal dialysis fluid from the catheter based on questionnaire
Measured: One months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Complication of Peritoneal Dialysis CatheterStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Reza Keramati, M.D., Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879734
- Sponsor's protocol ID
- IR.TUMS.VCR.REC.1395.247
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Performing Prophylactic Omentopexy and Lack of Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheters in Terms of Complications and Catheter Function
- ClinicalTrials.gov ID
- NCT02879734
- Acronym / sponsor ID
- IR.TUMS.VCR.REC.1395.247
- Keywords
- peritoneal dialysis, laparoscopy, omentum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 26 Aug 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 purpose of this study is to compare function of the peritoneal dialysis catheter in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.
Detailed description
Peritoneal dialysis is a know and accepted treatment in patients with end stage renal diseases. The is a safe, easy and cheap treatment modality in these patients. After introduction and development of laparoscopic procedures for insertion of peritoneal dialysis catheters, some prophylactic surgical techniques have been proposed as measures to reduce catheter malfunction. Omentopexy is among these techniques. The purpose of this study is to compare function of the peritoneal dialysis catheter (including inflow and outflow failure) in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Omentopexy | No intervention | –Patients that did not undergo prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter |
| With Omentopexy | Experimental | Other: Prophylactic laparoscopic omentopexyPatients that underwent prophylactic omentopexy during laparoscopic insertion of peritoneal dialysis catheter. Intervention = Prophylactic laparoscopic omentopexy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- End-stage renal failure in need of prolonged dialysis referred for insertion of peritoneal dialysis catheter
Key exclusion criteria (3 listed)
- Contraindications to laparoscopic surgery
- Coagulative disorder
- Death of participant due to other reasons before usage of peritoneal catheter
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 |
|---|---|---|
| Prophylactic laparoscopic omentopexyFixation of omentum with sutures to anterior abdominal wall during laparoscopic surgery | Other | With Omentopexy |
Primary outcome
Ability of the peritoneal catheter to pass the dialysis fluid
Time frame: One months
Inflow and outflow passage of the peritoneal dialysis fluid from the catheter based on questionnaire
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 8 Aug 2017.
- Individual participant dataSharing planned: No
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.
Mohammad Reza Keramati, M.D. principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic laparoscopic omentopexy in people with Mechanical Complication of Peritoneal Dialysis Catheter, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 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 8 Aug 2017. 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 Iran. 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?
Ability of the peritoneal catheter to pass the dialysis fluid (time frame: One months). 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 8 Aug 2017.