Intraperitoneal Lavage for Reducing Pain in Laparoscopy
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|ClinicalTrials.gov Identifier: NCT03290521|
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Procedure: intraperitoneal washing with saline solution Procedure: No washing||Not Applicable|
Patients will be fully and accurately informed on the type of intervention and will sign a specific informed consent, in accordance with CBM standards, both for the intervention to which the patient will undergo both for the study in question.
Randomization will be performed through a randomized randomization table generated by a computer. Patients will therefore be divided into two groups:
A - Yes Washing (SL) B - No Washing (NL) Prior to surgery, hemoglobin and PCR values will be evaluated in the preoperative.
Prior to the incision, an antibiotic prophylaxis will be performed with cefazoline 2gr intravenously.
The intervention in both groups involves the periombelic cutaneous incision and the sub-umbilical band. Introduction of 10mm led trocar based on open technique. The introduction of optics and CO2 insufflation allows the macroscopic visualization of the endotominal organs. The investigators proceed with the introduction of 3 additional 3-lane trocar accessories in the left iliac fossa, right and overlaid iliac thorax. You will perform a hysterectomy possibly associated with annessiectomy or myomectomy according to the surgical indication. Careful hemostasis is carried out. In the SL group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity. The surgery ends with the closure of the band and the breasts cutaneous. The parameters measured during the operation are: operating time, amount of CO2 injected (L), pneumoperitoneal pressure (mmHg). The operator surgeon is always the same.
In the postoperative period, the following parameters will be evaluated: hemoglobin, white blood cells, PCR, body temperature, recovery of intestinal activity, administration of toradol, paracetamol and possible morphine and postoperative postoperative pain, palpation, cough. The latter is evaluated through tables using the VAS visual scale: patients report the subjective characteristics of perceived postoperative pain by attributing a value of 0 (no pain) to 10 (worse pain than I can imagine). It assesses the occurrence of any complications in post-operative, infection and fever, which may require the patient's exclusion from the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Patients will therefore be divided into two groups:
A - Yes Washing (SL) B - No Washing (NL)
|Official Title:||The Role of Intraperitoneal Irrigation and Lavage With Normal Saline for Reduction of Postoperative Pain After Laparoscopic Hysterectomy and Myomectomy: A Randomized Controlled Trial|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||July 30, 2017|
|Actual Study Completion Date :||August 30, 2017|
Experimental: A - Yes Washing (SL)
In this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity.
Procedure: intraperitoneal washing with saline solution
intraperitoneal washing at the end of surgery
Experimental: B- No Washing (NL)
No washing was performed before the end of surgery
Procedure: No washing
- pain [ Time Frame: 17 months ]to evaluate the postoperative pain using VAS scale
- infections [ Time Frame: 17 months ]postoperative infections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290521
|Rome, Italy, 00128|
|Principal Investigator:||Roberto Angioli||Campus Bio-Medico University|