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Laparotomy for Cancer of the Female Reproductive System

Phase 4
Waitlist Available
Led By Sean C Dowdy
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours after surgery
Awards & highlights

Study Summary

This trial is studying whether giving liposomal bupivacaine with or without hydromorphone will improve pain control during the first 24 hours after surgery in patients with gynecological malignancies.

Eligible Conditions
  • Cancer of the Female Reproductive System

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Benefit of Analgesia Score (OBAS)
Secondary outcome measures
Additional fluid requirement after 24 hours of surgery
Cost of care
Cumulative 24 hour narcotic consumption
+10 more
Other outcome measures
Quality of Recovery-15

Side effects data

From 2015 Phase 2 trial • 48 Patients • NCT02317705
91%
Procedural pain
32%
Vomiting
27%
Nausea
25%
Anaemia
16%
Hypokalaemia
11%
Pyrexia
11%
Sinus tachycardia
11%
Infusion related reaction
9%
Abdominal distension
9%
Constipation
9%
Diarrhoea
7%
Pleural effusion
7%
Hypotension
7%
Urinary tract infection
7%
Dysphagia
7%
Ileus
7%
Procedural nausea
7%
Hyperglycaemia
7%
Hyperkalaemia
5%
Pruritus
5%
Electrocardiogram QT prolonged
5%
Pulmonary oedema
5%
Haemorrhagic anaemia
5%
Deep vein thrombosis
5%
Leukocytosis
5%
Anxiety
5%
Postoperative wound infection
5%
Sepsis
5%
Platelet count decreased
5%
Pneumonia
5%
Abdominal Pain
5%
Ascites
5%
Fluid overload
5%
Fatigue
2%
Seizure
2%
Lip infection
2%
Klebsiella infection
2%
Lacrimation increased
2%
Septic Shock
2%
Wound abscess
2%
Incision site cellulitis
2%
Acute kidney injury
2%
Bladder spasm
2%
Headache
2%
Paraesthesia
2%
Presyncope
2%
Pruritus generalised
2%
Skin irritation
2%
Urticaria
2%
Device related infection
2%
Haematoma
2%
Haematoma infection
2%
Haemorrhage
2%
Small intestinal obstruction
2%
Back pain
2%
Gastrooesophageal reflux disease
2%
Clostridium difficile infection
2%
Hallucination
2%
Confusional state
2%
Delirium
2%
Insomnia
2%
Atelectasis
2%
Hypoxia
2%
Wound abcess
2%
Plueral effusion
2%
Wound dehiscence
2%
Bronchitis
2%
Dyspnoea
2%
Chills
2%
Malaise
2%
Oedema peripheral
2%
Blood alkaline phosphatase increased
2%
Urine output decreased
2%
Tachycardia
2%
Ileus paralytic
2%
Bladder injury
2%
Gastrointestinal anastomotic leak
2%
Thrombocytosis
2%
Cellulitis
2%
Septic shock
2%
Vulvovaginal candidiasis
2%
Hypoalbuminaemia
2%
Hypocalcaemia
2%
Hyponatraemia
2%
Hypophosphataemia
2%
Pneumothorax
2%
Sneezing
2%
Haematuria
2%
Pollakiuria
2%
Urinary retention
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients Receiving OTL38

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (laparotomy, liposomal bupivacaine, hydromorphone)Experimental Treatment4 Interventions
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT.
Group II: Arm I (laparotomy, liposomal bupivacaine)Active Control3 Interventions
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydromorphone
2005
Completed Phase 4
~4340
Laparotomy
2010
Completed Phase 4
~1000
Liposomal Bupivacaine
2016
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,680 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,049 Total Patients Enrolled
Sean C Dowdy5.03 ReviewsPrincipal Investigator - Mayo Clinic
Mayo Clinic
5Patient Review
This man is a genius!

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what situations is Laparotomy often performed?

"Laparotomy is the traditional approach for treating permphigus. This procedure can also prove beneficial to patients struggling with acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

What is the aggregate figure of individuals engaged in this experiment?

"Affirmative. The data hosted on clinicaltrials.gov affirms that recruitment for this research study is currently underway, with the original post dating back to July 9th 2020 and a recent update having been made on July 18th 2022. 98 patients are being sought out at one medical facility."

Answered by AI

Is there a notable threat to patient safety associated with Laparotomy?

"Laparotomy is approved and thus has been rated 3 on a 1 to 3 scale by our Power team, as the trial is in its fourth phase."

Answered by AI

Does this research involve participants aged 45 or older?

"This medical trial only permits those aged 18 to 80 years old to participate. In addition, there are 19 research initiatives targeting minors and 150 for elderly individuals."

Answered by AI

Are there still openings available in this clinical trial?

"Per clinicaltrials.gov, this trial is recruiting now and has been since its initiation on July 9th 2020; the most recent amendment was made 7/18/2022."

Answered by AI

Has the Laparotomy procedure previously been studied in other contexts?

"Presently, 120 clinical trials are exploring Laparotomy. Of these investigations, 20 have already entered Phase 3 testing. Primarily located in the city of Philadelphia (PA), 163 different medical centers have launched studies for this form of treatment."

Answered by AI

To what demographic does this clinical trial cater?

"Eligibility for this medical trial requires that patients have malignancies and be between 18 to 80 years old. 98 individuals will ultimately participate in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
Sean C Dowdy, MD 2020. "Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04258631.
~22 spots leftby Apr 2025
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