HysterectomyNCT07109193
The Relationship Between Intraperitoneal Drain Placement and Postoperative Pain in Gynecologic Laparoscopy
An observational study of Hysterectomy, run by Assiut University.
Trial summary
To assess the effect of intraperitoneal drain placement on postoperative pain after Gynecologic laparoscopy To evaluate whether the use of drains contributes to improved other clinical outcomes Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Oct 2027
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of women undergoing elective laparoscopic gynecologic surgery at [Insert Hospital/Institution Name] over a [insert duration, e.g., 6-month or 12-month] period. Eligible participants will be adult females aged 18 to 65 years who are scheduled for non-oncologic, minimally invasive gynecologic procedures such as ovarian cystectomy, salpingectomy, diagnostic laparoscopy, or laparoscopic management of endometriosis.
Who may be able to join
- Elective procedure: Patients scheduled for elective pure laparoscopic gynecologic surgery (e.g., ovarian cystectomy, endometriosis resection, diagnostic laparoscopy).
- ASA Physical Status: I-II (i.e., healthy or mild systemic disease).
- BMI: 18-35 kg/m².
- Informed Consent: Able and willing to give written consent and comply with postoperative pain assessments.
Who cannot join
- 1 - Malignancy: Known or suspected gynecologic malignancy requiring staging or radical surgery.
- 2. Conversion: Intraoperative conversion to laparotomy.
- 3. Coagulopathy: Bleeding disorders or therapeutic anticoagulation that cannot be paused perioperatively.
- 4. Prior Major Pelvic Surgery: ≥ 2 previous open abdominal operations (to avoid confounding from adhesions).
- 5. Intra-Abdominal Infection: Active pelvic inflammatory disease or untreated urinary tract infection.
- 6. Chronic Pain/Opioid Use: Regular opioid use or chronic pelvic pain syndromes (endometriosis pain > 6 months).
- 7. Allergy/Contraindication: Allergy to standard analgesics or contraindication to intraperitoneal drain placement (e.g., severe adhesions).
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
To assess the effect of intraperitoneal drain placement on postoperative pain after Gynecologic laparoscopy To evaluate whether the use of drains contributes to improved other clinical outcomes
Read the detailed description
Operative laparoscopy is becoming the primary approach for treatment of benign gynaecologic diseases, as it is a less invasive procedure and can help shorten the length of hospitalization., Most complications occur during abdominal access or port placement, while other complications arise during abdominal insufflations, tissue dissection, and homeostasis. However, postoperative pain at the shoulder and upper abdomen has been shown to be the most common complaint in many studies. It has been hypothesized that this is due to CO2 residue, which causes stretching of the post distended diaphragm and peritoneum after prolonged surgery. The suprapubic pain comes directly from the surgical wound, which is also affected by postoperative abdominal distension Several methods have been recommended to improve postoperative pain for ambulatory procedures, including a pulmonary recruitment maneuver,intraperitoneal infusions with saline or analgesic drugs,low pressure laparoscopic surgery,and the prescription of different types of preoperative medicine.Studies have shown peritoneal gas drain to be a procedure that could potentially be used to alleviate postoperative pain. Many previous studies have reported good results from using this procedure. Recently, a systematic review mentioned that there was little evidence to support the effectiveness of intraperitoneal gas drain in reducing postoperative pain.
- Conditions
- Hysterectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Corelation between intraperitoneal drain placement and Postoperative pain in Gynecologic laparoscopy
Evalute post operative pain levels and discomfort through Visual Analouge Scale (VAS) score
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud qayed mohamed abed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109193
- Sponsor's protocol ID
- Intraperitoneal drain
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kerimoglu OS, Yilmaz SA, Pekin A, Incesu F, Dogan NU, Ilhan TT, Celik C. Effect of drainage on postoperative pain after laparoscopic ovarian cystectomy. J Obstet Gynaecol. 2015 Apr;35(3):287-9. doi: 10.3109/01443615.2014.948824. Epub 2014 Aug 20.
PubMed 25140836Abbott J, Hawe J, Srivastava P, Hunter D, Garry R. Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial. Obstet Gynecol. 2001 Jul;98(1):97-100. doi: 10.1016/s0029-7844(01)01383-7.
PubMed 11430964Swift G, Healey M, Varol N, Maher P, Hill D. A prospective randomised double-blind placebo controlled trial to assess whether gas drains reduce shoulder pain following gynaecological laparoscopy. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):267-70. doi: 10.1111/j.0004-8666.2002.00267.x.
PubMed 12230061
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Intraperitoneal Drain Placement and Postoperative Pain in Gynecologic Laparoscopy
- ClinicalTrials.gov ID
- NCT07109193
- Acronym / sponsor ID
- Intraperitoneal drain
- Conditions
- Hysterectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 7 Aug 2025 (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 assess the effect of intraperitoneal drain placement on postoperative pain after Gynecologic laparoscopy To evaluate whether the use of drains contributes to improved other clinical outcomes
Detailed description
Operative laparoscopy is becoming the primary approach for treatment of benign gynaecologic diseases, as it is a less invasive procedure and can help shorten the length of hospitalization., Most complications occur during abdominal access or port placement, while other complications arise during abdominal insufflations, tissue dissection, and homeostasis. However, postoperative pain at the shoulder and upper abdomen has been shown to be the most common complaint in many studies. It has been hypothesized that this is due to CO2 residue, which causes stretching of the post distended diaphragm and peritoneum after prolonged surgery. The suprapubic pain comes directly from the surgical wound, which is also affected by postoperative abdominal distension Several methods have been recommended to improve postoperative pain for ambulatory procedures, including a pulmonary recruitment maneuver,intraperitoneal infusions with saline or analgesic drugs,low pressure laparoscopic surgery,and the prescription of different types of preoperative medicine.Studies have shown peritoneal gas drain to be a procedure that could potentially be used to alleviate postoperative pain. Many previous studies have reported good results from using this procedure. Recently, a systematic review mentioned that there was little evidence to support the effectiveness of intraperitoneal gas drain in reducing postoperative pain.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of women undergoing elective laparoscopic gynecologic surgery at [Insert Hospital/Institution Name] over a [insert duration, e.g., 6-month or 12-month] period. Eligible participants will be adult females aged 18 to 65 years who are scheduled for non-oncologic, minimally invasive gynecologic procedures such as ovarian cystectomy, salpingectomy, diagnostic laparoscopy, or laparoscopic management of endometriosis.
Key inclusion criteria (4 listed)
- Elective procedure: Patients scheduled for elective pure laparoscopic gynecologic surgery (e.g., ovarian cystectomy, endometriosis resection, diagnostic laparoscopy).
- ASA Physical Status: I-II (i.e., healthy or mild systemic disease).
- BMI: 18-35 kg/m².
- Informed Consent: Able and willing to give written consent and comply with postoperative pain assessments.
Key exclusion criteria (7 listed)
- 1 - Malignancy: Known or suspected gynecologic malignancy requiring staging or radical surgery.
- 2. Conversion: Intraoperative conversion to laparotomy.
- 3. Coagulopathy: Bleeding disorders or therapeutic anticoagulation that cannot be paused perioperatively.
- 4. Prior Major Pelvic Surgery: ≥ 2 previous open abdominal operations (to avoid confounding from adhesions).
- 5. Intra-Abdominal Infection: Active pelvic inflammatory disease or untreated urinary tract infection.
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
Corelation between intraperitoneal drain placement and Postoperative pain in Gynecologic laparoscopy
Time frame: Baseline
Evalute post operative pain levels and discomfort through Visual Analouge Scale (VAS) score
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 7 Aug 2025.
- Background: PubMed 25140836Kerimoglu OS, Yilmaz SA, Pekin A, Incesu F, Dogan NU, Ilhan TT, Celik C. Effect of drainage on postoperative pain after laparoscopic ovarian cystectomy. J Obstet Gynaecol. 2015 Apr;35(3):287-9. doi: 10.3109/01443615.2014.948824. Epub 2014 Aug 20.
- Background: PubMed 11430964Abbott J, Hawe J, Srivastava P, Hunter D, Garry R. Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial. Obstet Gynecol. 2001 Jul;98(1):97-100. doi: 10.1016/s0029-7844(01)01383-7.
- Results publication: PubMed 12230061Swift G, Healey M, Varol N, Maher P, Hill D. A prospective randomised double-blind placebo controlled trial to assess whether gas drains reduce shoulder pain following gynaecological laparoscopy. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):267-70. doi: 10.1111/j.0004-8666.2002.00267.x.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, 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 4 inclusion and 7 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 7 Aug 2025. 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 Mahmoud Qayed (0201142914797, mahmoudkaeed8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corelation between intraperitoneal drain placement and Postoperative pain in Gynecologic laparoscopy (time frame: Baseline). 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 NCT07109193, which also lists 3 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 7 Aug 2025.