Diverticular Disease of Left Side of ColonDIVERTI-QDVNCT04730765
Quality of Life (QOL) After Elective Sigmoidectomy for Diverticular Diseases (DIVERTI)
An observational study of Diverticular Disease of Left Side of Colon, run by University Hospital, Caen.
Trial summary
Acute diverticulitis of the left colon is among the most common abdominal disorders. To date, both conservative therapy in uncomplicated stages and emergency surgery in perforated disease with peritonitis are consensual. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diverticular Disease of Left Side of Colon
- What is being tested?
- left elective colectomy (Surgical Experimental Group)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2021to 30 Sep 2022
- Phase
- Observational
- 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
Study population: The allocation to conservative or surgical therapy will be performed at the inclusion in the study. Possible indications for surgery are listed below : * Persisting abdominal complaints (smouldering diverticular disease) after uncomplicated diverticulitis (Classification of Diverticular Disease (CDD) Stage 1, modified Hinchey 0+Ia). * Persisting abdominal complaints after covered perforation and/or pericolic 'microabscesses' (1cm) (CDD Stage 2b). * Chronic or recurrent diverticulitis with persisting abdominal complaints * diverticulitis complicated by an abscess >1 cm * divericulitisin a patient requiring long-term immunosuppressive therapy (with the exception of a neoplastic disease undergoing treatment)
Who may be able to join
- Patient who has received informed information and has not expressed opposition to participation
- Francophone patient
- Patient affiliated to a social security or equivalent system
- Patient taken in charge for :
- smoldering DS after DS Hinchey I
- persistence of symptoms after DS complicated by a peri-sigmoid abscess <1cm with resolution of inflammation
Show all 10Show fewer
- DS complicated with an abscess >1cm (Hinchey II)
- Recurrent episodes of DS
- DS in a patient requiring long-term immunosuppressive therapy (except for neoplastic disease undergoing treatment)
- Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis (surgical experimental group) or patient not operated and medically treated (medical control group)
Who cannot join
- Subjects meeting only one of the following non-inclusion criteria may not be eligible to participate in the research:
- Patient who is a minor or over 70 years of age
- Patient undergoing emergency surgery for sigmoid diverticulitis due to a complication (peritonitis, hemorrhage, failure of drainage diverticular abscess)
- diverticulitis complicated by fistula and/or symptomatic stenosis
- Colorectal resection protected by an ostomy or Hartmann's intervention
- Discovery of colorectal cancer on the operating room
- Patient operated on for diverticulitis of the right colon
- Neoplastic disease under treatment and/or evolving
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assesment of Quality of Life and Digestive and Genitourinary Functional Sequelae After Elective Left Colectomy for Sigmoid Diverticulitis. National Multicenter Prospective Observational Study
Acute diverticulitis of the left colon is among the most common abdominal disorders. To date, both conservative therapy in uncomplicated stages and emergency surgery in perforated disease with peritonitis are consensual. The best treatment strategy for other situations (i.e., smoldering, healed abscesses, recurrences) is still under debate. On the other hand, the best treatment strategy for complicated disease as well as for recurrent stages is still under debate. In these cases, elective surgery can be proposed on a case-by-case basis. Current French guideline recommendations have been updated in 2017. In theory, the objective of elective surgical treatment is to prevent the recurrence and/or complication of the diverticulitis, that might lead to the creation of a stoma. In France, nearly 12,000 prophylactic colectomies for diverticulitis are performed per year. Importantly, elective surgical treatment is associated with the relevant intrinsic morbidity (9.6% major complications within the Sigma Trial), the potential need for unplanned stoma formation of 1%-14% and a significant risk of persisting postoperative complaints. Up to 25% of patients who have undergone a scheduled sigmoid colectomy suffer from ongoing abdominal symptoms. Levack et al found the risk of faecal incontinence to be 24.8% after a sigmoidectomy. Moreover, faecal urgency occurred in 19.6% of patients, and incompleteness of emptying occurred in 20.8%., altering their quality of life (QOL).
To out knowledge, few data are available in the literature concerning the evaluation of QOL after elective sigmoid colectomy. Although QOL was significantly improved after surgery compared to conservative medical treatment, these results were questionable due to the heterogeneity of the studies and the lack of direct comparison of the two therapeutic approaches. Only one recent randomized study reported similar results but this one was prematurely stopped due to inclusion difficulties. The evaluation of digestive and genitourinary functional sequelae is based only on short series, most often retrospective. In summary, evidence on disease-specific characteristics influencing postoperative quality of life is lacking.
The aim of this prospective multicenter study is : (i) to evaluate the QOL and functional sequelae at 6 and 12 months in patients operated on for elective left colectomy and, (ii) to compare them to a population of non-operating diverticulitis patients.
Read the detailed description
Design The DIVERTI-QOL study is a prospective, multicentre, and observational study. The study will start in February 2021. Recruitment will be completed in July 2021. Overall, the inclusion of 110 patients in each arm is planned. 37 french hospitals agreed to participate in this study.
Allocation for surgery
The allocation to conservative or surgical therapy will be performed at the inclusion in the study. Possible indications for surgery are listed below :
- Persisting abdominal complaints (smouldering diverticular disease) after uncomplicated diverticulitis (Classification of Diverticular Disease (CDD) Stage 1, modified Hinchey 0+Ia).
- Persisting abdominal complaints after covered perforation and/or pericolic 'microabscesses' (1cm) (CDD Stage 2b).
- Chronic or recurrent diverticulitis with persisting abdominal complaints
- diverticulitis complicated by an abscess >1 cm
- divericulitisin a patient requiring long-term immunosuppressive therapy (with the exception of a neoplastic disease undergoing treatment)
- Being tested
- left elective colectomy (Surgical Experimental Group), antibiotic therapy (medical Control Group)
- Keywords
- Quality Of Life, Elective colectomy, Diverticular diseases
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left elective colectomy (Surgical Experimental Group)Procedure or surgery
Conventional laparoscopic resection of the sigmoid colon is performed using four ports. The left colon is mobilised from the lateral side along Gerota's fascia. The splenic flexure is mobilised at the discretion of surgeons. The mesentery of the sigmoid colon is then medially fenestrated at the promontory level. The superior rectal artery as well as the inferior mesenteric artery and vein are identified and are cut using tissue-sealing devices. A linear stapler device is applied for division of the large intestine. The sigmoid is retracted through a Pfannenstiel incision or enlargement of the left lower abdominal incision. Colorectal anastomosis is performed using a double stapling technique following open resection of the affected colon.
antibiotic therapy (medical Control Group)Drug
Antibiotic treatement for 10 days by oral or intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Surgical Experimental Group | Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis Receives: Procedure: left elective colectomy (Surgical Experimental Group) | |
| Medical Control Group | Patient not operated and medically treated Receives: Drug: antibiotic therapy (medical Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative HrQoL 6months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)
The score consists of 36 questions or items rated from 0 to 4 (0 being the worst and 4 the best). The sum of the scores constitutes the overall quality of life score; the ideal score is 144. The items cover 5 dimensions or sub-scales: symptoms (19 items), physical condition (7 items), emotions (5 items), social integration (4 items) and the effect of medical or surgical treatment (1 item). The questionnaire is considered usable if the missing data do not concern more than 2 questions. The QOL score (global and sub-scales) is calculated for all complete answers.
36 questions
Measured: 6 months
Secondary outcomes (4)
Health-related QOL will also be assessed according to the 5 dimensions of the GIQLI but also using the EQ-5D-5L score. The EuroQdV 5-Dimensions 5-Level (EQ-5D-5L)
The EuroQdV 5-Dimensional 5-Level (EQ-5D-5L) is a widely used utility instrument. Its descriptive system consists of five questions that cover the dimensions of mobility, personal autonomy, daily activities, pain/comfort, anxiety/depression, each with five possible answers that qualitatively reflect the presence of a problem (no problem, mild, moderate, severe and extreme).
Measured: 6 and 12 months
Hostoperative HrQoL 12months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)
The score consists of 36 questions or items rated from 0 to 4 (0 being the worst and 4 the best). The sum of the scores constitutes the overall quality of life score; the ideal score is 144. The items cover 5 dimensions or sub-scales: symptoms (19 items), physical condition (7 items), emotions (5 items), social integration (4 items) and the effect of medical or surgical treatment (1 item). The questionnaire is considered usable if the missing data do not concern more than 2 questions. The QOL score (global and sub-scales) is calculated for all complete answers.
36 questions
Measured: 12 months
Digestive sequelae will be assessed using the LARS score, the French version of which is currently being validated, genitourinary sequelae will be assessed using a simplified questionnaire.
The LARS score developed and validated in Denmark includes 5 items: gas incontinence, liquid stool incontinence, fragmentation and urgency (specifying for each item the frequency: never, less than once a week or more than once a week) and stool frequency (specifying respectively more than 7, between 4 and 7, between 1 and 3 and less than one stool per 24 hours). It assesses how these functional digestive sequelae affect QOL, i.e. never, very little, often or all the time. There is no Prior Resection Syndrome (PRS) if the score is between 0 and 20, but there is a minor PRS if the score is between 21 and 29 and a major PRS if the score is between 30 and 42.
Measured: 6 and 12 months
Morbidity and mortality at 90 days will be assessed using the International Classification of Dindo-Clavian Disease and by follow-up
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Blood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention
- IIIa Intervention not under general anesthesia
- IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU-management
- IVa single organ dysfunction (including dialysis)
- IVb multiorgandysfunction Grade V Death of a patient
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 Sep 2021 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diverticular Disease of Left Side of ColonStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Association Francaise de Chirurgie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730765
- Sponsor's protocol ID
- 20-181
- Other IDs
- 2020-A02802-37
- Acronym
- DIVERTI-QDV
- Status last verified
- Mar 2021
- First submitted
- 26 Jan 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolkenstein HE, Consten ECJ, van der Palen J, van de Wall BJM, Broeders IAMJ, Bemelman WA, Lange JF, Boermeester MA, Draaisma WA; Dutch Diverticular Disease (3D) Collaborative Study Group. Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: 5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial). Ann Surg. 2019 Apr;269(4):612-620. doi: 10.1097/SLA.0000000000003033.
PubMed 30247329Forgione A, Guraya SY. Elective colonic resection after acute diverticulitis improves quality of life, intestinal symptoms and functional outcome: experts' perspectives and review of literature. Updates Surg. 2016 Mar;68(1):53-8. doi: 10.1007/s13304-016-0349-0. Epub 2016 Mar 25.
PubMed 27015932Schultz JK, Azhar N, Binda GA, Barbara G, Biondo S, Boermeester MA, Chabok A, Consten ECJ, van Dijk ST, Johanssen A, Kruis W, Lambrichts D, Post S, Ris F, Rockall TA, Samuelsson A, Di Saverio S, Tartaglia D, Thorisson A, Winter DC, Bemelman W, Angenete E. European Society of Coloproctology: guidelines for the management of diverticular disease of the colon. Colorectal Dis. 2020 Sep;22 Suppl 2:5-28. doi: 10.1111/codi.15140. Epub 2020 Jul 7.
PubMed 32638537Sohn M, Agha A, Iesalnieks I, Bremer S, Trum S, Di Cerbo F, Nerlich A, Lotz N, Klieser E, Hochrein A, Schredl P, Kalcheva D, Emmanuel K, Presl J. PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study. BMJ Open. 2020 Mar 24;10(3):e034385. doi: 10.1136/bmjopen-2019-034385.
PubMed 32209628
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Quality of Life and Digestive and Genitourinary Functional Sequelae After Elective Left Colectomy for Sigmoid Diverticulitis. National Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04730765
- Acronym / sponsor ID
- DIVERTI-QDV / 20-181
- Keywords
- Quality Of Life, Elective colectomy, Diverticular diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Association Francaise de Chirurgie
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 29 Jan 2021 (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.
Acute diverticulitis of the left colon is among the most common abdominal disorders. To date, both conservative therapy in uncomplicated stages and emergency surgery in perforated disease with peritonitis are consensual. The best treatment strategy for other situations (i.e., smoldering, healed abscesses, recurrences) is still under debate. On the other hand, the best treatment strategy for complicated disease as well as for recurrent stages is still under debate. In these cases, elective surgery can be proposed on a case-by-case basis. Current French guideline recommendations have been updated in 2017. In theory, the objective of elective surgical treatment is to prevent the recurrence and/or complication of the diverticulitis, that might lead to the creation of a stoma. In France, nearly 12,000 prophylactic colectomies for diverticulitis are performed per year. Importantly, elective surgical treatment is associated with the relevant intrinsic morbidity (9.6% major complications within the Sigma Trial), the potential need for unplanned stoma formation of 1%-14% and a significant risk of persisting postoperative complaints. Up to 25% of patients who have undergone a scheduled sigmoid colectomy suffer from ongoing abdominal symptoms. Levack et al found the risk of faecal incontinence to be 24.8% after a sigmoidectomy. Moreover, faecal urgency occurred in 19.6% of patients, and incompleteness of emptying occurred in 20.8%., altering their quality of life (QOL).
To out knowledge, few data are available in the literature concerning the evaluation of QOL after elective sigmoid colectomy. Although QOL was significantly improved after surgery compared to conservative medical treatment, these results were questionable due to the heterogeneity of the studies and the lack of direct comparison of the two therapeutic approaches. Only one recent randomized study reported similar results but this one was prematurely stopped due to inclusion difficulties. The evaluation of digestive and genitourinary functional sequelae is based only on short series, most often retrospective. In summary, evidence on disease-specific characteristics influencing postoperative quality of life is lacking.
The aim of this prospective multicenter study is : (i) to evaluate the QOL and functional sequelae at 6 and 12 months in patients operated on for elective left colectomy and, (ii) to compare them to a population of non-operating diverticulitis patients.
Detailed description
Design The DIVERTI-QOL study is a prospective, multicentre, and observational study. The study will start in February 2021. Recruitment will be completed in July 2021. Overall, the inclusion of 110 patients in each arm is planned. 37 french hospitals agreed to participate in this study.
Allocation for surgery
The allocation to conservative or surgical therapy will be performed at the inclusion in the study. Possible indications for surgery are listed below :
- Persisting abdominal complaints (smouldering diverticular disease) after uncomplicated diverticulitis (Classification of Diverticular Disease (CDD) Stage 1, modified Hinchey 0+Ia).
- Persisting abdominal complaints after covered perforation and/or pericolic 'microabscesses' (1cm) (CDD Stage 2b).
- Chronic or recurrent diverticulitis with persisting abdominal complaints
- diverticulitis complicated by an abscess >1 cm
- divericulitisin a patient requiring long-term immunosuppressive therapy (with the exception of a neoplastic disease undergoing treatment)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Experimental Group | – | Procedure: left elective colectomy (Surgical Experimental Group)Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis |
| Medical Control Group | – | Drug: antibiotic therapy (medical Control Group)Patient not operated and medically treated |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The allocation to conservative or surgical therapy will be performed at the inclusion in the study. Possible indications for surgery are listed below : * Persisting abdominal complaints (smouldering diverticular disease) after uncomplicated diverticulitis (Classification of Diverticular Disease (CDD) Stage 1, modified Hinchey 0+Ia). * Persisting abdominal complaints after covered perforation and/or pericolic 'microabscesses' (1cm) (CDD Stage 2b). * Chronic or recurrent diverticulitis with persisting abdominal complaints * diverticulitis complicated by an abscess >1 cm * divericulitisin a patient requiring long-term immunosuppressive therapy (with the exception of a neoplastic disease undergoing treatment)
Key inclusion criteria (10 listed)
- Patient who has received informed information and has not expressed opposition to participation
- Francophone patient
- Patient affiliated to a social security or equivalent system
- Patient taken in charge for :
- Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis (surgical experimental group) or patient not operated and medically treated (medical control group)
Key exclusion criteria (8 listed)
- Subjects meeting only one of the following non-inclusion criteria may not be eligible to participate in the research:
- Patient who is a minor or over 70 years of age
- Patient undergoing emergency surgery for sigmoid diverticulitis due to a complication (peritonitis, hemorrhage, failure of drainage diverticular abscess)
- diverticulitis complicated by fistula and/or symptomatic stenosis
- Colorectal resection protected by an ostomy or Hartmann's intervention
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 |
|---|---|---|
| left elective colectomy (Surgical Experimental Group)Conventional laparoscopic resection of the sigmoid colon is performed using four ports. The left colon is mobilised from the lateral side along Gerota's fascia. The splenic flexure is mobilised at the discretion of surgeons. The mesentery of the sigmoid colon is then medially fenestrated at the promontory level. The superior rectal artery as well as the inferior mesenteric artery and vein are identified and are cut using tissue-sealing devices. A linear stapler device is applied for division of the large intestine. The sigmoid is retracted through a Pfannenstiel incision or enlargement of the left lower abdominal incision. Colorectal anastomosis is performed using a double stapling technique following open resection of the affected colon. | Procedure or surgery | Surgical Experimental Group |
| antibiotic therapy (medical Control Group)Antibiotic treatement for 10 days by oral or intravenous administration | Drug | Medical Control Group |
Primary outcome
Postoperative HrQoL 6months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)
Time frame: 6 months
The score consists of 36 questions or items rated from 0 to 4 (0 being the worst and 4 the best). The sum of the scores constitutes the overall quality of life score; the ideal score is 144. The items cover 5 dimensions or sub-scales: symptoms (19 items), physical condition (7 items), emotions (5 items), social integration (4 items) and the effect of medical or surgical treatment (1 item). The questionnaire is considered usable if the missing data do not concern more than 2 questions. The QOL score (global and sub-scales) is calculated for all complete answers. 36 questions
4 secondary outcomes
Health-related QOL will also be assessed according to the 5 dimensions of the GIQLI but also using the EQ-5D-5L score. The EuroQdV 5-Dimensions 5-Level (EQ-5D-5L)
Time frame: 6 and 12 months
Hostoperative HrQoL 12months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)
Time frame: 12 months
Digestive sequelae will be assessed using the LARS score, the French version of which is currently being validated, genitourinary sequelae will be assessed using a simplified questionnaire.
Time frame: 6 and 12 months
Morbidity and mortality at 90 days will be assessed using the International Classification of Dindo-Clavian Disease and by follow-up
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Results publication: PubMed 30247329Bolkenstein HE, Consten ECJ, van der Palen J, van de Wall BJM, Broeders IAMJ, Bemelman WA, Lange JF, Boermeester MA, Draaisma WA; Dutch Diverticular Disease (3D) Collaborative Study Group. Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: 5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial). Ann Surg. 2019 Apr;269(4):612-620. doi: 10.1097/SLA.0000000000003033.
- Results publication: PubMed 27015932Forgione A, Guraya SY. Elective colonic resection after acute diverticulitis improves quality of life, intestinal symptoms and functional outcome: experts' perspectives and review of literature. Updates Surg. 2016 Mar;68(1):53-8. doi: 10.1007/s13304-016-0349-0. Epub 2016 Mar 25.
- Results publication: PubMed 32638537Schultz JK, Azhar N, Binda GA, Barbara G, Biondo S, Boermeester MA, Chabok A, Consten ECJ, van Dijk ST, Johanssen A, Kruis W, Lambrichts D, Post S, Ris F, Rockall TA, Samuelsson A, Di Saverio S, Tartaglia D, Thorisson A, Winter DC, Bemelman W, Angenete E. European Society of Coloproctology: guidelines for the management of diverticular disease of the colon. Colorectal Dis. 2020 Sep;22 Suppl 2:5-28. doi: 10.1111/codi.15140. Epub 2020 Jul 7.
- Results publication: PubMed 32209628Sohn M, Agha A, Iesalnieks I, Bremer S, Trum S, Di Cerbo F, Nerlich A, Lotz N, Klieser E, Hochrein A, Schredl P, Kalcheva D, Emmanuel K, Presl J. PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study. BMJ Open. 2020 Mar 24;10(3):e034385. doi: 10.1136/bmjopen-2019-034385.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease of Left Side of Colon, run by University Hospital, Caen.
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 10 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 31 Aug 2021. 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.
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 Arnaud ALVES, MDPhD (+33 2 31 06 44 97, alves-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative HrQoL 6months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI) (time frame: 6 months). 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 NCT04730765, which also lists 4 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 31 Aug 2021.