Abdominal PainNCT06193798
Diagnostic Laparoscopy for Unexplained Abdominal Pain
An observational study of Abdominal Pain, run by Assiut University.
Trial summary
To evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories in general surgery depatment Assuit university hospital Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to 11 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: To evalute the efficiency and safety of diagnostic laparoscopy for unexplained abdominal pain cases in general surgery depatment Assuit university hospital
Who may be able to join
- Patients with obscure abdominal pain
- Age from 18 years old up to 70 years old
Who cannot join
- Current use of narcotics
- patients have uncontrolled coagulopathy
- Patients are Haemodynamically unstable
- patients have Cardiopulmonary problems
- Patients refusing the diagnostic laparoscopy after routine investigations
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Laparoscopy For Unexplained Abdominal Pain Risks &Benefits
To evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories in general surgery depatment Assuit university hospital
Read the detailed description
Abdominal pain may be a simple thing or it may be a dangerous and life threatening one.It is very difficult to come to a correct diagnosis(1).Diagnostic laparoscopy gives many advantages in the management of many intra-abdominal conditions where the correct diagnosis could not establish clinically or even with the help of imaging studies(2).Diagnostic laparoscopy can be done under direct vision using simple instruments of laparoscopy. With advances in optics, laparoscopy allows visualization of entire peritoneal cavity and further makes possible histological diagnosis of target biopsy under vision(3).In case of diagnostic uncertainty, laparoscopy may help to avoid unnecessary laparotomy, provides accurate diagnosis, helps to plan surgical treatment, improves the outcome in the majority of patients with abdominal pain and allows surgeons to diagnose and treat many abdominal conditions that cannot be properly managed otherwise(4).Many factors like high diagnostic yield, its applicability and therapeutic management in both elective and emergency setups, reduced hospital stay, low morbidity, and expenditure have made this treatment modality most popular(5). On the otherhand there are Complications related to laparoscopic surgery up to one-half of complications occur at the time of abdominal access for camera or port placement , Others arise from abdominal insufflation, tissue dissection, and hemostasis .Conversion to an open procedure may be needed to manage complications (6).Recent treatises deficient in evalution of the role of lap in cases with vague abdominal pain for this the interest of our study is to evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories.
- Conditions
- Abdominal Pain
- Medical subject headings
- Abdominal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic laparoscopy for unexplained abdominal pain
For diagnosis any obscure abdominal pain
Measured: Diagnostic laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Mar 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran, Assiut University
- Investigators
- Mostafa Hamed, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193798
- Sponsor's protocol ID
- Diagnostic laparoscopy
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ning N, Xia SY, Ma B, Li R, DU XH. [Application of laparoscopic technique in acute abdomen of gastrointestinal surgery]. Zhonghua Wei Chang Wai Ke Za Zhi. 2013 Oct;16(10):960-2. Chinese.
PubMed 24158868
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Laparoscopy For Unexplained Abdominal Pain Risks &Benefits
- ClinicalTrials.gov ID
- NCT06193798
- Acronym / sponsor ID
- Diagnostic laparoscopy
- Conditions
- Abdominal Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 5 Jan 2024 (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.
To evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories in general surgery depatment Assuit university hospital
Detailed description
Abdominal pain may be a simple thing or it may be a dangerous and life threatening one.It is very difficult to come to a correct diagnosis(1).Diagnostic laparoscopy gives many advantages in the management of many intra-abdominal conditions where the correct diagnosis could not establish clinically or even with the help of imaging studies(2).Diagnostic laparoscopy can be done under direct vision using simple instruments of laparoscopy. With advances in optics, laparoscopy allows visualization of entire peritoneal cavity and further makes possible histological diagnosis of target biopsy under vision(3).In case of diagnostic uncertainty, laparoscopy may help to avoid unnecessary laparotomy, provides accurate diagnosis, helps to plan surgical treatment, improves the outcome in the majority of patients with abdominal pain and allows surgeons to diagnose and treat many abdominal conditions that cannot be properly managed otherwise(4).Many factors like high diagnostic yield, its applicability and therapeutic management in both elective and emergency setups, reduced hospital stay, low morbidity, and expenditure have made this treatment modality most popular(5). On the otherhand there are Complications related to laparoscopic surgery up to one-half of complications occur at the time of abdominal access for camera or port placement , Others arise from abdominal insufflation, tissue dissection, and hemostasis .Conversion to an open procedure may be needed to manage complications (6).Recent treatises deficient in evalution of the role of lap in cases with vague abdominal pain for this the interest of our study is to evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To evalute the efficiency and safety of diagnostic laparoscopy for unexplained abdominal pain cases in general surgery depatment Assuit university hospital
Key inclusion criteria (2 listed)
- Patients with obscure abdominal pain
- Age from 18 years old up to 70 years old
Key exclusion criteria (5 listed)
- Current use of narcotics
- patients have uncontrolled coagulopathy
- Patients are Haemodynamically unstable
- patients have Cardiopulmonary problems
- Patients refusing the diagnostic laparoscopy after routine investigations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic laparoscopy for unexplained abdominal pain
Time frame: Diagnostic laparoscopy
For diagnosis any obscure abdominal pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Background: PubMed 24158868Ning N, Xia SY, Ma B, Li R, DU XH. [Application of laparoscopic technique in acute abdomen of gastrointestinal surgery]. Zhonghua Wei Chang Wai Ke Za Zhi. 2013 Oct;16(10):960-2. Chinese.
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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.
Mostafa Hamed study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain, run by Assiut 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouran Mohsen, Doctor (01025729935, nouranmohsen112@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic laparoscopy for unexplained abdominal pain (time frame: Diagnostic laparoscopy). 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 NCT06193798, which also lists 1 linked publication.
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 22 Jan 2024.