Laparotomy for Cancer of the Female Reproductive System

Mayo Clinic in Rochester, Rochester, MN
Cancer of the Female Reproductive SystemLaparotomy - Procedure
Eligibility
18 - 80
Female

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

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Similar Trials

1
DT-216
1
Bupivacaine liposome
1
Bupivacaine with epinephrine plus dexamethasone - Group 2

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: At 24 hours after surgery

Hour 24
Quality of Recovery-15
Hour 24
Additional fluid requirement after 24 hours of surgery
Cost of care
Cumulative 24 hour narcotic consumption
Incidence of adverse events
Length of stay
Operating room time
Overall Benefit of Analgesia Score (OBAS)
Post-operative pain scores
Surgical time
Time to first analgesic request
Total and pain management related standardized costs
Use of intravenous (IV) patient-controlled analgesia
Use of intravenous rescue opioids
Weight gain following surgery

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
DT-216
1
Bupivacaine liposome
1
Bupivacaine with epinephrine plus dexamethasone - Group 2

Side Effects for

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

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Arm I (laparotomy, liposomal bupivacaine)
1 of 2
Arm II (laparotomy, liposomal bupivacaine, hydromorphone)
1 of 2

Active Control

Experimental Treatment

104 Total Participants · 2 Treatment Groups

Primary Treatment: Laparotomy · No Placebo Group · Phase 4

Arm II (laparotomy, liposomal bupivacaine, hydromorphone)Experimental Group · 4 Interventions: Hydromorphone, Liposomal Bupivacaine, Laparotomy, Questionnaire Administration · Intervention Types: Drug, Drug, Procedure, Other
Arm I (laparotomy, liposomal bupivacaine)ActiveComparator Group · 3 Interventions: Liposomal Bupivacaine, Laparotomy, Questionnaire Administration · Intervention Types: Drug, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydromorphone
FDA approved
Bupivacaine
FDA approved
Laparotomy
2010
Completed Phase 4
~1000

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 24 hours after surgery

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,279 Previous Clinical Trials
41,234,754 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,007 Previous Clinical Trials
3,513,114 Total Patients Enrolled
Sean C Dowdy5.03 ReviewsPrincipal Investigator - Mayo Clinic
Mayo Clinic
5Patient Review
This man is a genius!

Eligibility Criteria

Age 18 - 80 · Female Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a spinal condition or abnormality, such as spina bifida or lumbar spinal fusion, that may prevent safe participation in the study.
You have an allergy or cannot tolerate opioids, acetaminophen, or certain types of local anesthesia.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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