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The technique, safety, and cost-effectiveness of minimal invasive abdominal hysterectomy (MIAH) using standard laparotomy equipment
WEDNESDAY,
SEPTEMBER
6
Study Methods: This multicenter Danish, randomized trial included women undergoing hysterectomy for benign disease from 1 April 1996 to 31 April 2000. The sample size was estimated as 320 women based on the assumption that subtotal hysterectomy reduces the incidence of urological complications by 10% (test of significance at 5% level, power 80%). The endpoints are postoperative complications, bladder, bowel and sexual function, pelvic pain, descensus of the vaginal top/cervix uteri, vaginal bleedings and psychological well-being. These are measured by validated, questionnaires filled out by the women before and 8 weeks, _ year, one, five and 10 years after the operation. Information about postoperative complications was collected by files filled out by the operating gynecologist. The automatic randomisation procedure was computer generated using block randomisation and stratification by center and ovarian status. An independent datamonitoring committee (DMC) has supervised the study. Their interim analyses regarding postoperative complications and urinary incontinence have not caused the study to be stopped. Results: As 300 patients have been included by 15 January 2000, recruitment for the study is estimated to be finished by May 2000. Data regarding the complications during the first eight weeks after the operation will be presented. Conclusions: present data from the first randomised trial of total versus subtotal hysterectomy.
FC3.16.04 THE TECHNIQUE, SAFETY, AND COST-EFFECTIVENESS OF MINIMAL INVASIVE ABDOMINAL HYSTERECTOMY (MIAH) USING STANDARD LAPAROTOMY EQUIPMENT F. C. Gupta, Dept OBIGYN, University of Manitoba, Winnipeg, Manitoba, Canada Objectives: To demonstrate the technique, safety, and cost effectiveness of MIAH. Study Methods: One hundred and fifty-two women with non-malignant disease who were not suitable for vagina hysterectomy were included in this study. Hospital stays were compared with hysterectomies done by open laparotomy, vaginal and laparoscopic assisted vaginal hysterectomy (LAVH) techniques. Results: One hundred and twenty-seven women had TAH and 25 women had sub-total abdominal hysterectomy by choice. Spinal anesthesia was used in 122 women. The average weight of women was 69 kg with 40 women ranging form 80 to 160 kg. Sixty-five women had previous major abdominal surgery. Average weight of uterus was 183 grams, ranging from 44 to 1400 grams. Average surgical time was 54 minutes. No major complications encountered. Average length of hospital stay was 2.2 days compared to regional hospital stay of 4.4 days for abdominal hysterectomy, 3.5 days for vaginal hysterectomy and 2.7 days for LAVH. Conclusions: The technique of MIAH using standard open surgery equipment is safe, decreases patient morbidity and is cost effective.
FC3.16.05 TOTAL LAPAROSCOPIC HYSTERECTOMY VERSUS TOTAL ABDOMINAL HYSTERECTOMY: A CONFRONT OF 101 VS 100 CASES IN A PROSPECTIVE RANDOMIZED STUDY G. Cucinella, G. Gugliotta, B. Adile, Dept. OBIGYN, Villa Sofia Hospital, Palermo, Italy. Objectives: In this prospective randomized study, 101 cases of laparoscopic hysterectomy (LH) were compared to 100 cases of the traditional abdominal hysterectomy (AH). Patients were enrolled in this study from January 1997 and September 1999 at our Dept. of OBIGYN, Villa Sofia Hospital. Materials and Methods: The criteria for choosing LH were generally based on uterus volume which should not exceed that of 18 weeks pregnancy. The indications were the same for both LH and AH included: abnormal uterine bleeding or menorrhagia in 30 pts, enlarged uterus with myomas in 60 pts, pelvic pain in 27 pts, abnormalities of pelvic floor in 15 pts and adnexal mass in 19 pts. The study was randomized and patients had given their informed consent to undergo either LH or AH. Blood loss during LH was calculated as the difference between the volume of liquid introduced and the volume of liquid aspirated during the operation. Post-operative pain was assessed in three days after surgery using the visual analogic scale
45
(VAS) from O=no pain to lO=max pain. A temperature of 38°C starting from the second post-operative day was considered as post-operative fever. The following parameters were also evaluated: post-operative drop of hemoglobin (Hb) complications, duration of post-operative stay. Results: The average time employed for LH was about 104.1* 26.98 min (range 72-163). Average intraoperative blood loss was significantly lower in LH as opposed to AH, with lower first post-operative day Hb drop in the pts who underwent LH (table I). It was never necessary to convert LH to abdominal. Patients who underwent LH had less intense post-operative pain than pts in the group of AH (table II). Post-operative complications in the LH group were fever in one pt. And a ureteralvaginal fistula diagnosed 10 days after surgery in one patient, for which it was necessary to introduce a ureteral splint. In the AH two cases of hematoma of the vaginal cuff and 4 cases of fever. Table I : Comparison of post-operative abdominal operations
results of laparoscopic
and
Parameters
Laparoscopic hysterectomy (No. pts: 101)
Abdominal hysterectomy (No. pts: 101)
P value T test
Ane Body weight Parity Uterine weight (gm) Blood losses (ml) Post-operative day 1 Hb drop (gmiml) Post-operative stay
47.8 f 7.42 62.71 f 4.49 2.27 f 1.48 368 f 125.3 140 f 41.5
47.6 f 7.39 64.14 f 4.52 2.35 f 1.42 389 f 143.9 406 f 103.9
P-ns P-ns P-ns P-ns P
0.37 f 0.22 2.38 f 0.30
1.59 f 0.35 6.23 f 1.85
P
Data presented as mean f SD
ns = non-significant
Table II: The comparison abdominal hysterectomy
pain for laparoscopic
Post-operative Day 1’ Day 2’ Day 3’
pain (VAS)
of postoperative
and
Laparoscopic hysterectomy
Abdominal hysterectomy
4.1 f 1.2 2.3 f 1.6 1.0*0.7
6.9 f 1.8 5.4e1.3 3.1eo.9
Data are presented as mean f SD ‘P
FC3.16.06 ROLE OF SUPRACERVICAL HYSTERECTOMY IN THE TREATMENT OF MENORRHAGIA V Vavala, A. Monaco, E. Solima, G. Matonti, Ob/Gyn Dept. Ospedale Degli Infermi, Biella, Italy Objectives: to compare intraoperative and postoperative outcome of supracervical hysterectomy Materials and Methods: Between 1997 and 1999,253 women underwent hysterectomy for unresponsive to medical treatment of menorrhagia at Ob/Gyn Dept.of Biella hospital. Of these operations, 58.7% were performed by Supracervical Hysterectomy. The remainder, were performed either by total abdominal hysterectomy or vaginal hysterectomy. Comparative data of these surgical techniques concerning patients’ characteristics, blood loss, operating time, hospital stay, uterine weights, postoperatively used analgesics, bladder and rectal dysfunction were recorded Conclusion Supracervical hysterectomy patients showed a statistically significant reduction of intraoperative and postoperative complication rate. Bladder dysfunction symptoms were more frequent in patients submitted to total hysterectomy either laparotomic or vaginal.
SEPTEMBER
6
Study Methods: This multicenter Danish, randomized trial included women undergoing hysterectomy for benign disease from 1 April 1996 to 31 April 2000. The sample size was estimated as 320 women based on the assumption that subtotal hysterectomy reduces the incidence of urological complications by 10% (test of significance at 5% level, power 80%). The endpoints are postoperative complications, bladder, bowel and sexual function, pelvic pain, descensus of the vaginal top/cervix uteri, vaginal bleedings and psychological well-being. These are measured by validated, questionnaires filled out by the women before and 8 weeks, _ year, one, five and 10 years after the operation. Information about postoperative complications was collected by files filled out by the operating gynecologist. The automatic randomisation procedure was computer generated using block randomisation and stratification by center and ovarian status. An independent datamonitoring committee (DMC) has supervised the study. Their interim analyses regarding postoperative complications and urinary incontinence have not caused the study to be stopped. Results: As 300 patients have been included by 15 January 2000, recruitment for the study is estimated to be finished by May 2000. Data regarding the complications during the first eight weeks after the operation will be presented. Conclusions: present data from the first randomised trial of total versus subtotal hysterectomy.
FC3.16.04 THE TECHNIQUE, SAFETY, AND COST-EFFECTIVENESS OF MINIMAL INVASIVE ABDOMINAL HYSTERECTOMY (MIAH) USING STANDARD LAPAROTOMY EQUIPMENT F. C. Gupta, Dept OBIGYN, University of Manitoba, Winnipeg, Manitoba, Canada Objectives: To demonstrate the technique, safety, and cost effectiveness of MIAH. Study Methods: One hundred and fifty-two women with non-malignant disease who were not suitable for vagina hysterectomy were included in this study. Hospital stays were compared with hysterectomies done by open laparotomy, vaginal and laparoscopic assisted vaginal hysterectomy (LAVH) techniques. Results: One hundred and twenty-seven women had TAH and 25 women had sub-total abdominal hysterectomy by choice. Spinal anesthesia was used in 122 women. The average weight of women was 69 kg with 40 women ranging form 80 to 160 kg. Sixty-five women had previous major abdominal surgery. Average weight of uterus was 183 grams, ranging from 44 to 1400 grams. Average surgical time was 54 minutes. No major complications encountered. Average length of hospital stay was 2.2 days compared to regional hospital stay of 4.4 days for abdominal hysterectomy, 3.5 days for vaginal hysterectomy and 2.7 days for LAVH. Conclusions: The technique of MIAH using standard open surgery equipment is safe, decreases patient morbidity and is cost effective.
FC3.16.05 TOTAL LAPAROSCOPIC HYSTERECTOMY VERSUS TOTAL ABDOMINAL HYSTERECTOMY: A CONFRONT OF 101 VS 100 CASES IN A PROSPECTIVE RANDOMIZED STUDY G. Cucinella, G. Gugliotta, B. Adile, Dept. OBIGYN, Villa Sofia Hospital, Palermo, Italy. Objectives: In this prospective randomized study, 101 cases of laparoscopic hysterectomy (LH) were compared to 100 cases of the traditional abdominal hysterectomy (AH). Patients were enrolled in this study from January 1997 and September 1999 at our Dept. of OBIGYN, Villa Sofia Hospital. Materials and Methods: The criteria for choosing LH were generally based on uterus volume which should not exceed that of 18 weeks pregnancy. The indications were the same for both LH and AH included: abnormal uterine bleeding or menorrhagia in 30 pts, enlarged uterus with myomas in 60 pts, pelvic pain in 27 pts, abnormalities of pelvic floor in 15 pts and adnexal mass in 19 pts. The study was randomized and patients had given their informed consent to undergo either LH or AH. Blood loss during LH was calculated as the difference between the volume of liquid introduced and the volume of liquid aspirated during the operation. Post-operative pain was assessed in three days after surgery using the visual analogic scale
45
(VAS) from O=no pain to lO=max pain. A temperature of 38°C starting from the second post-operative day was considered as post-operative fever. The following parameters were also evaluated: post-operative drop of hemoglobin (Hb) complications, duration of post-operative stay. Results: The average time employed for LH was about 104.1* 26.98 min (range 72-163). Average intraoperative blood loss was significantly lower in LH as opposed to AH, with lower first post-operative day Hb drop in the pts who underwent LH (table I). It was never necessary to convert LH to abdominal. Patients who underwent LH had less intense post-operative pain than pts in the group of AH (table II). Post-operative complications in the LH group were fever in one pt. And a ureteralvaginal fistula diagnosed 10 days after surgery in one patient, for which it was necessary to introduce a ureteral splint. In the AH two cases of hematoma of the vaginal cuff and 4 cases of fever. Table I : Comparison of post-operative abdominal operations
results of laparoscopic
and
Parameters
Laparoscopic hysterectomy (No. pts: 101)
Abdominal hysterectomy (No. pts: 101)
P value T test
Ane Body weight Parity Uterine weight (gm) Blood losses (ml) Post-operative day 1 Hb drop (gmiml) Post-operative stay
47.8 f 7.42 62.71 f 4.49 2.27 f 1.48 368 f 125.3 140 f 41.5
47.6 f 7.39 64.14 f 4.52 2.35 f 1.42 389 f 143.9 406 f 103.9
P-ns P-ns P-ns P-ns P
0.37 f 0.22 2.38 f 0.30
1.59 f 0.35 6.23 f 1.85
P
Data presented as mean f SD
ns = non-significant
Table II: The comparison abdominal hysterectomy
pain for laparoscopic
Post-operative Day 1’ Day 2’ Day 3’
pain (VAS)
of postoperative
and
Laparoscopic hysterectomy
Abdominal hysterectomy
4.1 f 1.2 2.3 f 1.6 1.0*0.7
6.9 f 1.8 5.4e1.3 3.1eo.9
Data are presented as mean f SD ‘P
FC3.16.06 ROLE OF SUPRACERVICAL HYSTERECTOMY IN THE TREATMENT OF MENORRHAGIA V Vavala, A. Monaco, E. Solima, G. Matonti, Ob/Gyn Dept. Ospedale Degli Infermi, Biella, Italy Objectives: to compare intraoperative and postoperative outcome of supracervical hysterectomy Materials and Methods: Between 1997 and 1999,253 women underwent hysterectomy for unresponsive to medical treatment of menorrhagia at Ob/Gyn Dept.of Biella hospital. Of these operations, 58.7% were performed by Supracervical Hysterectomy. The remainder, were performed either by total abdominal hysterectomy or vaginal hysterectomy. Comparative data of these surgical techniques concerning patients’ characteristics, blood loss, operating time, hospital stay, uterine weights, postoperatively used analgesics, bladder and rectal dysfunction were recorded Conclusion Supracervical hysterectomy patients showed a statistically significant reduction of intraoperative and postoperative complication rate. Bladder dysfunction symptoms were more frequent in patients submitted to total hysterectomy either laparotomic or vaginal.